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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 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

40

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 1
Oral RAL and FTC/TDF for 72 weeks
Legemiddel: Raltegravir
400 mg tablet taken orally twice daily
Andre navn:
  • RAL
Legemiddel: 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 navn:
  • FTC/TDF

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbeidspartnere

Adult AIDS Clinical Trials Group

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2008

Primær fullføring (Faktiske)

1. januar 2009

Studiet fullført (Faktiske)

1. april 2010

Datoer for studieregistrering

Først innsendt

16. april 2008

Først innsendt som oppfylte QC-kriteriene

16. april 2008

Først lagt ut (Anslag)

18. april 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. november 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. oktober 2021

Sist bekreftet

1. oktober 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A5248
  • 10532 (DAIDS ES)
  • ACTG A5248

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