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Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals

3. august 2018 opdateret af: Gary Simon, George Washington University

A Multi-Center Comparison of Raltegravir to Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV-Infected Individuals Naive to Antiretroviral Therapy

This program is designed to study the efficacy, safety, lipid effects and tolerability of raltegravir compared to lopinavir/ritonavir, in patients with HIV-I infection who have not received prior antiretroviral therapy. All patients will receive concomitant therapy with Truvada.

Studieoversigt

Detaljeret beskrivelse

It is hypothesized that (1) the raltegravir regimen will have similar efficacy in terms of both viral suppression as well as increases in CD4 cell counts and (2) raltegravir will have significantly less impact on plasma lipids, lipoproteins and lipoproteins subtypes, compared with lopinavir/ritonavir.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

6

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20037
        • George Washington University Medical Faculty Associates

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Documented HIV infection confirmed by western blot or HIV RNA.
  2. At least 18 years of age.
  3. Less than 1 week of prior antiretroviral therapy.
  4. In the opinion of the investigator, patients should be clinically stable. Patients may be on chronic suppressive therapy for opportunistic infections such as MAC or CMV.
  5. Patients who are of reproductive potential agree to use an acceptable method of birth control throughout the study. Acceptable methods include an intrauterine device (IUD), diaphragm with spermicide, condoms, or abstinence.
  6. HIV RNA > 5000 copies/ml. No restriction on CD4 cell count.
  7. A negative urine pregnancy test on the day of initiation of therapy.

Exclusion Criteria:

  1. Prior treatment with >1week of antiretroviral therapy.
  2. Patient requires or is anticipated to require any of the prohibited medications noted in the protocol.
  3. HIV RNA < 5000 prior to receiving therapy.
  4. Baseline resistance to any of the study regimen drugs on genotype testing.
  5. Patients with acute hepatitis due to any cause or clinically significant chronic liver disease.
  6. Patient with severe renal insufficiency defined as a calculated creatinine clearance at time of screening <30mL/min, based on the Cockcroft-Gault equation which is as follows (and 0.85X this value for females): Clcr(mL/min) = (l40-age) x weight (in kg)72 x serum creatinine (mg/dL).
  7. Patient has a condition (including but not limited to alcohol or other substance abuse) which in the opinion of the investigator would interfere with patient compliance or safety.
  8. A female patient who is pregnant, breast-feeding, or expecting to conceive or donate eggs during the study; or a male patient who is planning to impregnate or provide sperm donation during the study is excluded.
  9. Inability to obtain signed informed consent from a patient age 18 or older.
  10. Patient has significant hypersensitivity or other contraindication to any of the components of the study drug.
  11. Patients who should be treated for hyperlipidemia as per NCEPIII guidelines and patients who are currently receiving lipid-lowering therapy are excluded.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Raltegravir plus Truvada
Raltegravir (400mg), 1 tablet, administered twice daily (BID) and Truvada (Emtricitabine/Tenofovir disoproxil fumarate) (200mg/300mg), 1 tablet administered once daily (QD)
1, 400mg tablet twice a day, with Truvada 1 tablet once a day
Andre navne:
  • Isentress
1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)
Andre navne:
  • Emtricitabin/Tenofovir disoproxilfumarat
Aktiv komparator: Lopinavir/Ritonavir plus Truvada
Lopinavir/Ritonavir (400mg/100mg) (Kaletra), 2 tablets administered twice daily (BID) and Truvada (Emtricitabine/Tenofovir disoproxil fumarate) (200mg/300mg), 1 tablet administered once daily (QD)
1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)
Andre navne:
  • Emtricitabin/Tenofovir disoproxilfumarat
2 tablets twice a day, with Truvada 1 tablet once a day
Andre navne:
  • Kaletra

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Absolute Change in CD4 Cell Counts
Tidsramme: 24 and 48 weeks
24 and 48 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Change is Plasma Lipids, Lipoproteins and Lipoprotein Subtypes.
Tidsramme: 24 weeks
24 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Gary Simon, MD, PhD, George Washington University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2008

Primær færdiggørelse (Faktiske)

1. februar 2010

Studieafslutning (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først indsendt

29. februar 2008

Først indsendt, der opfyldte QC-kriterier

10. marts 2008

Først opslået (Skøn)

11. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. august 2018

Sidst verificeret

1. august 2018

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-infektioner

Kliniske forsøg med Raltegravir

3
Abonner