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Study of Viral Load Decay Rates in HIV Infected Participants Starting Treatment With Raltegravir (RAL) and Emtricitabine/Tenofovir Disoproxil Fumarate (TDF)

28. oktober 2021 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

First-Phase Viral Decay Rates in Treatment-Naive Subjects Initiating Treatment With Raltegravir (RAL) and Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF): A Pilot Study

The HIV integrase inhibitor, raltegravir (RAL), which was recently approved by the FDA, has been shown in several trials to be highly effective. The purpose of this trial is to estimate the viral load decay rate in treatment-naive HIV infected participants receiving RAL and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Recent data suggests that early virologic response to HIV interventions may be predictive of long-term virologic outcomes. Defining early decay in viral load through carefully performed studies of viral dynamics may be a useful tool for assessing the likely outcome of long-term treatment. It may also be a useful screening tool to define which combinations should be studied further. In this trial, the viral load decay rate will be estimated in HIV infected, treatment-naive participants receiving RAL and FTC/TDF.

This study will last approximately 72 weeks. All participants will take RAL and FTC/TDF for 72 weeks. RAL will be provided by the study. FTC/TDF will not be provided.

This study will consist of 16 study visits. These visits will occur at study entry, Days 2, 7, 10, 14, 21, 28, and 56, and Weeks 12, 16, 20, 24, 36, 48, 60, and 72. Blood collection and pharmacokinetic studies will occur at all study visits. Self-reported adherence assessments will be submitted at each visit. A targeted physical exam will occur at most visits. Liver function tests and urine collection will occur at select visits. Pregnancy tests will occur whenever pregnancy is suspected.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • San Diego, California, Forenede Stater, 92103
        • UCSD Antiviral Research Center CRS
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado Hospital CRS
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University CRS
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21205
        • Johns Hopkins University CRS
      • Baltimore, Maryland, Forenede Stater, 21201
        • IHV Baltimore Treatment CRS
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110-1010
        • Washington University Therapeutics (WT) CRS
    • New York
      • New York, New York, Forenede Stater, 10037
        • Harlem ACTG CRS
      • Rochester, New York, Forenede Stater, 14642
        • Univ. of Rochester ACTG CRS
      • Rochester, New York, Forenede Stater, 14607
        • Trillium Health ACTG CRS
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44109
        • MetroHealth CRS
      • Columbus, Ohio, Forenede Stater, 43210
        • Ohio State University CRS
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02906
        • The Miriam Hospital Clinical Research Site (TMH CRS) CRS
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37204
        • Vanderbilt Therapeutics (VT) CRS
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Houston AIDS Research Team CRS

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:

  • HIV infected
  • Antiretroviral treatment naive
  • Viral load at least 10,000 and less than 300,000 copies/ml within 42 days prior to study entry
  • Agree to use appropriate form of contraception. More information on this criterion can be found in the protocol.

Exclusion Criteria:

  • Received HIV-specific immunizations within 6 months prior to study entry
  • Received immunizations within 6 months prior to study entry
  • Known allergy or sensitivity to study drugs
  • Any participant with an acute AIDS-defining opportunistic infection (OI) who is not clinically stable or who has not been on therapy for the OI for at least 30 days prior to study entry
  • Treatment with immune modulators or any investigational therapy within 30 days prior to study entry
  • Evidence of HIV seroconversion within 6 months prior to study entry
  • Illness requiring systemic treatment and/or hospitalization
  • Substance abuse that, in the opinion of the investigator, would interfere with adherence to study requirements
  • Requirement for any current medications that are prohibited with any study medication. More information on this criterion can be found in the protocol.
  • Evidence of any major resistance-associated mutation on any genotype performed prior to study entry or at the time of screening. More information on this criterion can be found in the protocol.
  • Abnormal laboratory values. More information on this criterion can be found in the protocol.
  • Pregnant or breastfeeding

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Oral RAL and FTC/TDF for 72 weeks
Medicin: Raltegravir
400 mg tablet taken orally twice daily
Andre navne:
  • RAL
Medicin: Emtricitabine/tenofovir disoproxil fumarate
Fixed dose tablet containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate taken once daily. FTC/TDF will not be provided by the study and must be obtained by the particpant's health care provider.
Andre navne:
  • FTC/TDF

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Viral load decay rates
Tidsramme: Through Day 56
Through Day 56

Sekundære resultatmål

Resultatmål
Tidsramme
Viral load decay rates
Tidsramme: From Weeks 24 to 72
From Weeks 24 to 72
Proportion of participants with a viral load less than 50 copies/ml
Tidsramme: At Weeks 24, 48, and 72
At Weeks 24, 48, and 72
Safety and tolerability. More information on this criterion can be found in the protocol.
Tidsramme: Throughout study
Throughout study
CD4 and CD8 count
Tidsramme: Throughout study
Throughout study
Resistance mutations to RAL, FTC, and TDF
Tidsramme: Throughout study
Throughout study
Minimum concentration (Cmin) for RAL, FTC, and TDF
Tidsramme: Throughout study
Throughout study
Changes in viral load
Tidsramme: At Day 7
At Day 7
Self-reported adherence
Tidsramme: Throughout study
Throughout study
Cell-associated proviral DNA, LTR circular DNA, and integrated proviral DNA
Tidsramme: Throughout study
Throughout study
Viral load
Tidsramme: From Week 24 to Week 72
From Week 24 to Week 72

Samarbejdspartnere og efterforskere

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbejdspartnere

Adult AIDS Clinical Trials Group

Efterforskere

  • Studiestol: Adriana Andrade, MD, MPH, Johns Hopkins University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. maj 2008

Primær færdiggørelse (Faktiske)

1. januar 2009

Studieafslutning (Faktiske)

1. april 2010

Datoer for studieregistrering

Først indsendt

16. april 2008

Først indsendt, der opfyldte QC-kriterier

16. april 2008

Først opslået (Skøn)

18. april 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A5248
  • 10532 (DAIDS ES)
  • ACTG A5248

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

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Jordan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner