Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
16 januari 2015 uppdaterad av: Gilead Sciences
A Phase 3B Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed-Dose Combination (FTC/TDF) to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (EVG/COBI/FTC/TDF) Single-Tablet Regimen (STR) in Virologically Suppressed, HIV-1 Infected Patients
This study will evaluate the efficacy of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF)) single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus Truvada® (FTC/TDF) at baseline in maintaining HIV-1 RNA < 50 copies/mL at Week 12 in virologically suppressed, HIV-1 infected adults.
This study will also evaluate the safety, tolerability, and efficacy of Stribild over 24 and 48 weeks of treatment.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
48
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
Los Angeles, California, Förenta staterna, 90027
- Kaiser Permanente Los Angeles
-
Los Angeles, California, Förenta staterna, 90036
- Peter J. Ruane, MD, Inc.
-
Los Angeles, California, Förenta staterna, 90069
- Anthony Mills MD, Inc
-
-
District of Columbia
-
Washington, District of Columbia, Förenta staterna, 20009
- Dupont Circle Physician's Group
-
Washington, District of Columbia, Förenta staterna, 20036
- Capital Medical Associates, PC
-
-
Florida
-
Orlando, Florida, Förenta staterna, 32803
- Orlando Immunology Center
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02215
- Community Research Initiative of New England
-
-
Texas
-
Austin, Texas, Förenta staterna, 78705
- Central Texas Clinical Research
-
Houston, Texas, Förenta staterna, 77098
- Gordon E. Crofoot, MD, PA
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Ability to understand and sign a written informed consent form
Virologically stable on the current first antiretroviral regimen consisting only of raltegravir twice daily plus FTC/TDF continuously for ≥ 6 months preceding the screening visit and
- have documented undetectable plasma HIV-1 RNA levels ≥ 6 months preceding the screening visit (measured at least twice using the same assay) and
- have never experienced two consecutive HIV-1 RNA above detectable levels after first achieving a confirmed HIV-1 RNA level below detectable levels on the first regimen
- HIV-1 RNA < 50 copies/mL at the screening visit
- Have a genotype prior to starting initial antiretroviral therapy and have no known resistance to any of the study agents at any time
- Normal ECG
- Hepatic transaminases ≤ 5 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL
- Adequate hematologic function
- Serum amylase ≤ 5 x ULN
- Estimated glomerular filtration rate ≥ 70 mL/min
- Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active, practice sexual abstinence or have a vasectomized partner from screening throughout the duration of the study period and for 30 days following the last dose of study drug
- Females who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
- Males must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product or must be non heterosexually active, practice sexual abstinence, or be vasectomized
Exclusion Criteria:
- New AIDS defining condition diagnosed within the 21 days prior to screening
- Females who are breastfeeding
- Positive serum pregnancy test (female of childbearing potential)
- Individuals with acute or chronic hepatitis B or hepatitis C co-infection
- Individuals experiencing decompensated cirrhosis
- Have an implanted defibrillator or pacemaker
- Current alcohol or substance abuse that would interfere with compliance
- A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma
- Active, serious infections requiring parenteral antibiotic or antifungal therapy within 21 days prior to the baseline visit
- Receiving any investigational drugs
- Participation in any other clinical trial without prior approval from the sponsor
- Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study
- Any other clinical condition or prior therapy that would make the individual unsuitable for the study or unable to comply with the dosing requirements
- Receiving ongoing therapy or anticipated to need to initiate drugs or herbal/natural supplements during the study that are contraindicated or not recommended for use, including drugs not to be used with Stribild; or individuals with known allergies to the excipients of the Stribild single tablet regimen
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Stribild
Participants will switch to Stribild for 48 weeks.
|
Elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily with food
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12
Tidsram: Week 12
|
The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
|
Week 12
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities
Tidsram: Up to 48 weeks plus 30 days
|
This outcome measure assessed the safety and tolerability profile of Stribild.
Treatment-emergent adverse events (AEs) and graded laboratory abnormalities occurring from baseline up to 30 days following the last dose of study drug were summarized.
|
Up to 48 weeks plus 30 days
|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48
Tidsram: Weeks 24 and 48
|
The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
|
Weeks 24 and 48
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2012
Primärt slutförande (Faktisk)
1 november 2012
Avslutad studie (Faktisk)
1 juli 2013
Studieregistreringsdatum
Först inskickad
2 februari 2012
Först inskickad som uppfyllde QC-kriterierna
10 februari 2012
Första postat (Uppskatta)
15 februari 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
26 januari 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 januari 2015
Senast verifierad
1 januari 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Blodburna infektioner
- Smittsamma sjukdomar
- Sexuellt överförbara sjukdomar, virala
- Sexuellt överförbara sjukdomar
- Lentivirusinfektioner
- Retroviridae-infektioner
- Immunsystemets sjukdomar
- Långsamma virussjukdomar
- HIV-infektioner
- Förvärvat immunbristsyndrom
- Immunologiska bristsyndrom
- Anti-infektionsmedel
- Antivirala medel
- Anti-HIV-medel
- Antiretrovirala medel
- Elvitegravir, Cobicistat, Emtricitabin, Tenofovir Disoproxil Fumarate Läkemedelskombination
Andra studie-ID-nummer
- GS-US-236-0123
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .