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Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination

8. september 2008 oppdatert av: National Institute of Allergy and Infectious Diseases (NIAID)

A Pilot Study of Early Treatment Intensification of Antiretroviral Therapy

The purpose of this study is to see if adding 1 drug to an anti-HIV drug combination early in treatment against HIV can lower the viral load (amount of HIV in the blood) to a level so low that it cannot be measured (undetectable). The drug that will be added to a treatment is abacavir (ABC).

Many patients who take 3 anti-HIV drugs together are able to achieve very low viral loads, for example, viral loads below 50 copies/ml. However, some patients taking only 3 drugs are not able to achieve a viral load this low. Doctors hope that, by adding the drug ABC to a current treatment, a viral load below 50 copies/ml can be achieved. Doctors would like to find out if it is effective to start patients on 3 drugs and then add another drug (treatment intensification) if the treatment is not working as well as hoped.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Combination antiretroviral therapy can offer patients potent suppression of HIV replication and improved immunologic functioning. However, despite aggressive antiretroviral regimens currently in use, only about 50 to 60 percent of patients attain plasma viral loads below 50 copies/ml after 24 weeks. Initiating treatment with a 4-drug regimen may increase this percentage, but this may also contribute to patient non-adherence, drug-related toxicities, potential cross-resistance to drugs used in future regimens, and high financial costs. Another strategy is early intensification (adding a single drug to an existing regimen) in patients who are at risk for attaining incomplete viral suppression after 24 weeks of therapy. ABC may produce a significant antiviral effect when used as an intensification agent in patients on a stable antiretroviral regimen. The results of this study will offer insight into the potential benefits of early treatment intensification.

Patients entering this study will have initiated potent antiretroviral therapy. Between 60 and 90 days [AS PER AMENDMENT 1/9/01: 60 and 104 days] after beginning their background regimen, patients are randomized to add either ABC (Arm A) or a matching placebo (Arm B) for 12 weeks. Patients completing 12 weeks of treatment continue on study for an additional 24 weeks to Week 36. Patients discontinue treatment if virologic failure occurs at any time. Patients still return to the clinic for HIV-1 RNA measurements at Weeks 12 and 36, depending on when discontinuation occurred. Patients who discontinue treatment at or after Week 12 due to virologic failure are offered open-label ABC for the remainder of the study (through Week 36). Blood samples are collected at Weeks 4, 8, 12, 20, 28, and 36. Plasma samples for population sequencing of HIV-1 PR and RT genes are collected on all patients at study entry and at the time of virologic failure. Baseline genotype (presence or absence of PR and RT resistance mutations and number of resistance mutations) is correlated to treatment outcome. Samples from the time of failure are analyzed for the accumulation of additional resistance mutations. [AS PER AMENDMENT 5/5/00: Patients and their primary care physicians will be unblinded to the patient's treatment after the study is completed at Week 36 or if virologic failure occurs at or after Week 12 [AS PER AMENDMENT 1/9/01: or if ABC hypersensitivity is suspected].]

Studietype

Intervensjonell

Registrering

80

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90095
        • UCLA CARE Ctr
      • Menlo Park, California, Forente stater, 94025
        • Willow Clinic
      • San Jose, California, Forente stater, 951282699
        • Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
      • Stanford, California, Forente stater, 943055107
        • San Mateo AIDS Program / Stanford Univ
      • Stanford, California, Forente stater, 943055107
        • Stanford Univ Med Ctr
      • Torrance, California, Forente stater, 90502
        • Harbor UCLA Med Ctr
    • Colorado
      • Denver, Colorado, Forente stater, 80262
        • Univ of Colorado Health Sciences Ctr
    • Florida
      • Miami, Florida, Forente stater, 331361013
        • Univ of Miami School of Medicine
    • Georgia
      • Atlanta, Georgia, Forente stater, 30308
        • Emory Univ
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Northwestern Univ Med School
      • Chicago, Illinois, Forente stater, 60612
        • Cook County Hosp
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • Johns Hopkins Hosp
      • Baltimore, Maryland, Forente stater, 212052196
        • State of MD Div of Corrections / Johns Hopkins Univ Hosp
    • Missouri
      • St Louis, Missouri, Forente stater, 63112
        • St Louis Regional Hosp / St Louis Regional Med Ctr
    • New York
      • Buffalo, New York, Forente stater, 14215
        • SUNY / Erie County Med Ctr at Buffalo
      • New York, New York, Forente stater, 10003
        • Beth Israel Med Ctr
      • New York, New York, Forente stater, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York, New York, Forente stater, 10032
        • Columbia Presbyterian Med Ctr
      • New York, New York, Forente stater, 10021
        • Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
      • Rochester, New York, Forente stater, 14642
        • Univ of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 275997215
        • Univ of North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke Univ Med Ctr
    • Ohio
      • Cincinnati, Ohio, Forente stater, 452670405
        • Univ of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Univ of Pennsylvania at Philadelphia
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Philadelphia Veterans Administration Med Ctr
    • South Carolina
      • West Columbia, South Carolina, Forente stater, 29169
        • Julio Arroyo
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37203
        • Vanderbilt Univ Med Ctr
    • Texas
      • Dallas, Texas, Forente stater, 75390
        • Univ of Texas, Southwestern Med Ctr of Dallas
    • Washington
      • Seattle, Washington, Forente stater, 98104
        • Univ of Washington
  • Puerto Rico
      • San Juan, Puerto Rico, 009365067
        • Univ of Puerto Rico

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

13 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have been taking anti-HIV therapy that includes at least 3 anti-HIV drugs and is an acceptable anti-HIV drug combination for 60 to 104 days before study treatment. Patients must not have changed any of the drugs in the 28 days before study entry. (This study has been changed by extending the number of days that anti-HIV therapy has been received.)
  • Have a viral load greater than 500 but less than or equal to 10,000 copies/ml and have had a significant decrease in viral load between 49 and 84 days after starting this anti-HIV therapy. (This study has been changed by extending the length of time of viral load decrease.)
  • Are at least 13 years old (consent of parent or guardian required if under 18).
  • Agree to practice abstinence or use barrier method of birth control (such as condoms) during the study and for 3 months after.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have ever taken ABC.
  • Have received anti-HIV therapy for more than 104 days in the past. (This study has been changed by extending the number of days that anti-HIV therapy has been received.)
  • Have a fever for 7 days in the 30 days before study entry.
  • Have cancer, including Kaposi's sarcoma, that requires chemotherapy.
  • Have an active infection that requires treatment in the 21 days before study entry.
  • Have any opportunistic (AIDS-related) infection or disease that requires a change in medication in the 14 days before study entry.
  • Have any medical condition or history of an illness that the doctor feels would place them at risk or make them unable to complete the study.
  • Are taking drugs that affect the immune system or any experimental anti-HIV drugs, except for their current drug combination.
  • Are taking St. John's wort. (This study has been changed. Previously, patients taking St. John's wort were eligible.)
  • Have received a vaccine in the 21 days before study entry.
  • Are pregnant or breast-feeding.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Masking: Dobbelt

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)

Etterforskere

  • Studiestol: Pablo Tebas
  • Studiestol: John Bartlett

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. november 1999

Studiet fullført

1. april 2001

Datoer for studieregistrering

Først innsendt

17. januar 2000

Først innsendt som oppfylte QC-kriteriene

30. august 2001

Først lagt ut (Anslag)

31. august 2001

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. september 2008

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2008

Sist bekreftet

1. juni 2003

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ACTG A5064
  • AACTG A5064

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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