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KIVEXA Vs TRUVADA, Both Administered With Efavirenz, In ART-Naive Subjects (ASSERT)

7 avril 2011 mis à jour par: GlaxoSmithKline

Study of Once-Daily Abacavir/Lamivudine Versus Tenofovir/Emtricitabine, Administered With Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects

Recently, the fixed-dose combinations (FDC) KIVEXA™ (abacavir/lamivudine) and TRUVADA (tenofovir disoproxil fumarate/emtricitabine) have facilitated the usage of once-daily regimens. However data from head-to-head randomized trials comparing these two FDCs as part of an initial regimen are not available at present. The long-term toxicity profiles of these regimens are of particular importance, as treatment of HIV is currently life-long and therefore, minimizing long-term toxicity and maximizing adherence and duration of regimen maintenance are critical therapy objectives.

The primary endpoint is estimated glomerular filtration rate (GFR), as measured by the modified diet in renal disease (MDRD) equation, a validated estimate of renal function.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Type d'étude

Interventionnel

Inscription (Réel)

392

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
      • Berlin, Allemagne, 13353
        • GSK Investigational Site
      • Hamburg, Allemagne, 20246
        • GSK Investigational Site
      • Hamburg, Allemagne, 20146
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Allemagne, 69115
        • GSK Investigational Site
    • Bayern
      • Muenchen, Bayern, Allemagne, 80335
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Allemagne, 30159
        • GSK Investigational Site
      • Hannover, Niedersachsen, Allemagne, 30625
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Duesseldorf, Nordrhein-Westfalen, Allemagne, 40237
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Allemagne, 45122
        • GSK Investigational Site
    • Sachsen
      • Leipzig, Sachsen, Allemagne, 04170
        • GSK Investigational Site
  • Belgique
      • Brugge, Belgique, 8000
        • GSK Investigational Site
      • Bruxelles, Belgique, 1000
        • GSK Investigational Site
      • Charleroi, Belgique, 6000
        • GSK Investigational Site
      • Gent, Belgique, 9000
        • GSK Investigational Site
      • Leuven, Belgique, 3000
        • GSK Investigational Site
  • Danemark
      • Aalborg, Danemark, DK-9000
        • GSK Investigational Site
      • Aarhus N, Danemark, 8200
        • GSK Investigational Site
      • Hvidovre, Danemark, DK-2650
        • GSK Investigational Site
      • Koebenhavn, Danemark, DK-2100
        • GSK Investigational Site
      • Odense C, Danemark, 5000
        • GSK Investigational Site
  • Espagne
      • Madrid, Espagne, 28034
        • GSK Investigational Site
      • Valencia, Espagne, 46015
        • GSK Investigational Site
  • France
      • Garches, France, 92380
        • GSK Investigational Site
      • Levallois-Perret, France, 92300
        • GSK Investigational Site
      • Saint Denis Cedex 01, France, 93205
        • GSK Investigational Site
  • Irlande
      • Dublin, Irlande, 8
        • GSK Investigational Site
      • Dublin, Irlande, 7
        • GSK Investigational Site
  • Italie
    • Emilia-Romagna
      • Ferrara, Emilia-Romagna, Italie, 44100
        • GSK Investigational Site
      • Modena, Emilia-Romagna, Italie, 41100
        • GSK Investigational Site
      • Rimini, Emilia-Romagna, Italie, 47900
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italie, 00149
        • GSK Investigational Site
    • Lombardia
      • Legnano (MI, Lombardia, Italie, 20025
        • GSK Investigational Site
      • Milano, Lombardia, Italie, 20127
        • GSK Investigational Site
      • Milano, Lombardia, Italie, 20142
        • GSK Investigational Site
    • Piemonte
      • Torino, Piemonte, Italie, 10149
        • GSK Investigational Site
  • L'Autriche
      • Innsbruck, L'Autriche, A-6020
        • GSK Investigational Site
      • Salzburg, L'Autriche, A-5020
        • GSK Investigational Site
      • Vienna, L'Autriche, A-1090
        • GSK Investigational Site
      • Vienna, L'Autriche, A-1140
        • GSK Investigational Site
  • Le Portugal
      • Amadora, Le Portugal, 2720-276
        • GSK Investigational Site
  • Lettonie
      • Riga, Lettonie, LV 1006
        • GSK Investigational Site
  • Pays-Bas
      • Alkmaar, Pays-Bas, 1815 JD
        • GSK Investigational Site
      • Den Haag, Pays-Bas, 2512 VA
        • GSK Investigational Site
      • Groningen, Pays-Bas, 9713 GZ
        • GSK Investigational Site
      • Rotterdam, Pays-Bas, 3078 HT
        • GSK Investigational Site
      • Utrecht, Pays-Bas, 3584 CX
        • GSK Investigational Site
  • Royaume-Uni
      • Birmingham, Royaume-Uni, B4 6DH
        • GSK Investigational Site
      • Birmingham, Royaume-Uni, WS2 9PS
        • GSK Investigational Site
      • Farnworth, Bolton, Royaume-Uni, BL4 0JR
        • GSK Investigational Site
      • Gloucester, Royaume-Uni, GL1 3NN
        • GSK Investigational Site
      • Leicester, Royaume-Uni, LE1 5WW
        • GSK Investigational Site
      • London, Royaume-Uni, E1 1BB
        • GSK Investigational Site
      • London, Royaume-Uni, SW10 9TH
        • GSK Investigational Site
      • London, Royaume-Uni, NW3 2QG
        • GSK Investigational Site
      • London, Royaume-Uni, SW17 0QT
        • GSK Investigational Site
      • London, Royaume-Uni, N18 1QX
        • GSK Investigational Site
      • Middlesborough, Royaume-Uni, TS4 3BW
        • GSK Investigational Site
      • Sheffield, Royaume-Uni, S10 2JF
        • GSK Investigational Site
    • Lancashire
      • Manchester, Lancashire, Royaume-Uni, M8 5RB
        • GSK Investigational Site
    • London
      • Woolwich, London, London, Royaume-Uni, SE18 4QH
        • GSK Investigational Site
    • Midlothian
      • Edinburgh, Midlothian, Royaume-Uni, EH4 2XU
        • GSK Investigational Site
    • Sussex East
      • Brighton, Sussex East, Royaume-Uni, BN2 1ES
        • GSK Investigational Site
  • Suisse
      • Basel, Suisse, 4031
        • GSK Investigational Site
      • Bern, Suisse, 3010
        • GSK Investigational Site
      • Lausanne, Suisse, 1011
        • GSK Investigational Site
      • St Gallen, Suisse, 9007
        • GSK Investigational Site
      • Zuerich, Suisse, 8091
        • GSK Investigational Site
      • Zurich, Suisse, 8038
        • GSK Investigational Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Subject is at least 18 years of age.
  • Subject is antiretroviral-naïve (defined as having no previous therapy with any NNRTI and 14 days of prior therapy with any other antiretroviral).
  • Subject has plasma HIV-1 RNA 1,000 copies/mL at screening. This test may be repeated once within the 45-day screening window.
  • Subject is willing and able to understand and provide written informed consent prior to participation in this study.

  • A female is eligible to enter and participate in the study if she is of:

    1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or,
    2. Child-bearing potential, has a negative pregnancy test at screen and agrees to one of the following methods of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the approved product label and the instructions of a physician):

Complete abstinence from intercourse from 2 weeks prior to administration of the investigational products, throughout the study, and for at least 2 weeks after discontinuation of all study medications Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide). Hormonal contraception will not be considered adequate for inclusion into this study Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year.

Sterilization (female subject or male partner of female subject).

  • Prior to randomization, subjects must have been screened and be negative for the HLA-B*5701 allele. Test may be performed by local laboratory and results must be available for source document verification according to local practices.

Exclusion Criteria:

  • Subject is in the initial acute phase of a CDC Clinical Category C infection at Baseline.
  • Subject is enrolled in one or more investigational drug protocols, which may impact HIV RNA suppression.
  • Subject is, in the opinion of the Investigator, unable to complete the study dosing period and protocol evaluations and assessments.
  • Subject is either pregnant or breastfeeding.
  • Subject suffers from a serious medical condition, which in the opinion of the Investigator would compromise the safety of the subject.
  • Subject has a history of inflammatory bowel disease or other gastrointestinal dysfunction.
  • Subject has any acute laboratory abnormality at screening.
  • Subject has an estimated creatinine clearance within the screening period <50mL/min via the Cockcroft-Gault method.
  • Alanine aminotransferase (ALT) >5 times the upper limit of normal.
  • Subjects with a history of thyroid disease, hyperparathyroid disease, chronic hyper or hypocalcemia, vitamin D deficiency, or receiving thyroid hormone or parathyroid hormone replacement within 28 days prior to screening.
  • Subjects with a history of systemic inflammatory arthritis.
  • Subjects who are hepatitis B positive at screening.
  • Subject requires treatment with radiation therapy or cytotoxic chemotherapeutic agents.
  • Subject has received treatment with an HIV-1 immunotherapeutic vaccine or any agents with documented activity against HIV-1 in vitro within 28 days prior to Screening, or an anticipated need during the study.
  • Subjects who require treatment with any of the following medications within 28 days of commencement of investigational product, or an anticipated need during the study:
  • Medications with significant drug-drug interactions with efavirenz:voriconazole, terfenadine, astemizole, cisapride, ergot alkaloids (dihydroergotamine, ergonovine, ergotamine, methylergonovine), midazolam, triazolam, St. John's wort, carbamazepine, phenytoin, phenobarbital, rifampin, pimozide, bepridil
  • Medications which may impact on bone mineral density: oral or systemic corticosteroids, anticonvulsants, heparin, warfarin, cyclosporine, bisphosphonates, calcitonin, parathyroid hormone, Vitamin D supplements and analogues, Calcium supplements, oestrogen or progesterone replacement (oral hormonal contraception permitted), raloxifene, tamoxifen, testosterone or anabolic steroid replacement/supplements.
  • Systemic interleukins or interferons
  • Subject has a history of allergy to any of the protocol-specified medications or any excipients therein.
  • Subject has evidence of genotypic resistance at screening (according to central lab interpretation) or prior documented evidence of genotypic and/or phenotypic (above threshold for reduced susceptibility) resistance to any of the following drugs: efavirenz, abacavir, lamivudine, tenofovir, emtricitabine.
  • Subjects who are unsuitable for DEXA scanning should be excluded, including 1) Less than three vertebra in the range of L1 to L4 that are suitable for BMD measurement by DEXA, or 2) Bilateral hip replacement.
  • The subject has previously participated in an experimental drug and/or vaccine trial(s) within 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine - whichever is longer, prior to screening for the study.
  • The subject will participate simultaneously in another clinical study.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: ABC/3TC + EFV
Médicament: Abacavir/lamivudine and efavirenz
Comparateur actif: TDF/FTC + EFV
Médicament: Tenofovir/Emtricitabine and efavirenz

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48
Délai: Baseline, Week 48
Change from baseline was calculated as the Week 48 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine; BMI, body mass index.
Baseline, Week 48

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24
Délai: Baseline, Week 24
Change from baseline was calculated as the Week 24 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine.
Baseline, Week 24
Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96
Délai: Baseline, Week 96
Change from baseline was calculated as the Week 96 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^s, meters squared; Scr, serum creatinine.
Baseline, Week 96
Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24
Délai: Baseline, Week 24
Change from baseline was calculated as the Week 24 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram; CG, Cockcroft-Gault.
Baseline, Week 24
Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48
Délai: Baseline, Week 48
Change from baseline was calculated as the Week 48 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram.
Baseline, Week 48
Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96
Délai: Baseline, Week 96
Change from baseline was calculated as the Week 96 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram.
Baseline, Week 96
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24
Délai: Baseline, Week 24
mL, milliliter; min, minute; m^2, meters squared
Baseline, Week 24
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48
Délai: Baseline, Week 48
mL, milliliter; min, minute; m^2, meters squared
Baseline, Week 48
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96
Délai: Baseline, Week 96
mL, milliliter; min, minute; m^2, meters squared
Baseline, Week 96
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24
Délai: Baseline, Week 24
Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.
Baseline, Week 24
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48
Délai: Baseline, Week 48
Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.
Baseline, Week 48
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96
Délai: Baseline, Week 96
Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.
Baseline, Week 96
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
Délai: Baseline, Week 24
BMD is a measure (grams [g] per centimeters cubed [cm^3]) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Baseline, Week 24
Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
Délai: Baseline, Week 24
BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Baseline, Week 24
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
Délai: Baseline, Week 48
BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Baseline, Week 48
Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
Délai: Baseline, Week 48
BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Baseline, Week 48
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
Délai: Baseline, Week 96
BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Baseline, Week 96
Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
Délai: Baseline, Week 96
BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Baseline, Week 96
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24
Délai: Baseline, Week 24
BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.
Baseline, Week 24
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48
Délai: Baseline, Week 48
BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.
Baseline, Week 48
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96
Délai: Baseline, Week 96
BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.
Baseline, Week 96
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24
Délai: Week 24
The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a "normal, healthy, 30-year-old female". The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD.
Week 24
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48
Délai: Week 48
The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a "normal, healthy, 30-year-old female". The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD.
Week 48
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96
Délai: Week 96
The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a "normal, healthy, 30-year-old female". The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD.
Week 96
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24
Délai: Baseline to Week 24
An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.
Baseline to Week 24
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48
Délai: Baseline to Week 48
An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.
Baseline to Week 48
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96
Délai: Baseline to Week 96
An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.
Baseline to Week 96
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24
Délai: Baseline, Week 24
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.
Baseline, Week 24
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48
Délai: Baseline, Week 48
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.
Baseline, Week 48
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96
Délai: Baseline, Week 96
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.
Baseline, Week 96
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24
Délai: Baseline, Week 24
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.
Baseline, Week 24
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48
Délai: Baseline, Week 48
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.
Baseline, Week 48
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96
Délai: Baseline, Week 96
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.
Baseline, Week 96
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24
Délai: Baseline, Week 24
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.
Baseline, Week 24
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48
Délai: Baseline, Week 48
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.
Baseline, Week 48
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96
Délai: Baseline, Week 96
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.
Baseline, Week 96
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24
Délai: Baseline, Week 24
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high.
Baseline, Week 24
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48
Délai: Baseline, Week 48
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high.
Baseline, Week 48
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96
Délai: Baseline, Week 96
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150->200 mg/dL, borderline high; 200-<500 mg/dL, high;>= 500 mg/dL, very high.
Baseline, Week 96
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24
Délai: Week 24
The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment.
Week 24
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48
Délai: Week 48
The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment.
Week 48
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96
Délai: Week 96
The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug therapy.
Week 96
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24
Délai: Week 24
HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.
Week 24
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48
Délai: Week 48
HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.
Week 48
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96
Délai: Week 96
HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.
Week 96
Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24
Délai: Baseline, Week 24
CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.
Baseline, Week 24
Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48
Délai: Baseline, Week 48
CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.
Baseline, Week 48
Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96
Délai: Baseline, Week 96
CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.
Baseline, Week 96
Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96
Délai: Week 96
Viral resistance was measured using blood samples collected from participants throughout the study. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor. Virological failure was defined as any one of: participant does not achieve a 1 log10 copies (cop)/mL decrease in plasma HIV-1 RNA by Week (Wk) 4, or has two consecutive plasma HIV-1 RNA measures >=400 cop/mL separated by at least 2-4 wk after being previously <=400 cop/mL on/after Wk 4, or has two consecutive plasma HIV-1 RNA measures >400 cop/mL separated by at least 2-4 wk on/after Wk 24.
Week 96
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized
Délai: Baseline to Week 96
Participants were asked at each visit whether or not they utilized unplanned healthcare resources.
Baseline to Week 96

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96
Délai: Baseline, Week 96
Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline albumin value by the urine creatinine value. Albumin is measured in milligrams per millimole (mg/mmol).
Baseline, Week 96
Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96
Délai: Baseline, Week 96
Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline B2M value by the urine creatinine value. B2M, beta 2 microglobulin (measured in mg/mmol).
Baseline, Week 96
Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96
Délai: Baseline, Week 96
Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline NAG value by the urine creatinine value. NAG, N-acetyl-B-glucosaminidase (measured in micromoles per hour per millimole [umol/h/mmol]).
Baseline, Week 96
Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96
Délai: Baseline, Week 96
Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline RBP value by the urine creatinine value. RBP, retinol binding protein (measured in micrograms per millimole [ug/mmol]).
Baseline, Week 96
Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96
Délai: Baseline, Week 96
P1NP is a bone biomarker that was analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.
Baseline, Week 96
Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96
Délai: Baseline, Week 96
Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.
Baseline, Week 96
Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96
Délai: Baseline, Week 96
Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.
Baseline, Week 96
Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96
Délai: Baseline, Week 96
Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.
Baseline, Week 96

Collaborateurs et enquêteurs

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Parrainer

GlaxoSmithKline

Publications et liens utiles

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Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2007

Achèvement primaire (Réel)

1 décembre 2009

Achèvement de l'étude (Réel)

1 décembre 2009

Dates d'inscription aux études

Première soumission

24 octobre 2007

Première soumission répondant aux critères de contrôle qualité

24 octobre 2007

Première publication (Estimation)

25 octobre 2007

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

12 avril 2011

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 avril 2011

Dernière vérification

1 avril 2011

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CNA109586

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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