The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients With No Symptoms of Infection
Completed · Phase 4
Conditions studied: HIV Infections
In brief
To evaluate the ability of the combination of indinavir, zidovudine, and lamivudine to suppress HIV-1 infection as measured by: (1) the maintenance of HIV-1 serum viral RNA below the limit of detection of the most sensitive validated assay (ultradirect assay) and (2) absence of evidence of infectious virus in lymph node, cerebrospinal fluid (CSF), peripheral mononuclear cells (PBMCs), and semen. It is hypothesized that the administration of indinavir, zidovudine, and lamivudine will result in: 1. No evidence of infectious virus in lymph node tissue, CSF, PBMCs, and semen samples in 50% of patients who have undetectable viral RNA by the most sensitive validated assay available (ultradirect assay) for at least 48 weeks. 2. Sustained suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the ultradirect assay for at least 48 weeks in at least 25% of patients. 3. Suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the standard Amplicor assay (i.e., negative) in at least 90% of patients by Week 16. 4. Suppression of HIV-1 infection, suggesting eradication of the virus as measured by maintenance of serum viral RNA to below the limit of detection of the ultradirect assay for at least 24 weeks after discontinuation of indinavir, zidovudine, and lamivudine in patients who have maintained this level of suppression for at least 120 weeks on therapy.
Key facts
- Study ID
- NCT00002179
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 200
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have:
- HIV-1 seropositive status.
- CD4 count >= 500 cells/mm3.
- Serum viral RNA level > 1000 copies/ml.
You may not qualify if…
- Prior Medication:
- Excluded:
- Previous antiretroviral therapy.
Where it is running
- Univ of Alabama at Birmingham — Birmingham, Alabama, United States
- LAC - USC Med Ctr — Los Angeles, California, United States
- AIDS Community Research Consortium — Redwood City, California, United States
- San Francisco Gen Hosp — San Francisco, California, United States
- Yale Univ School of Medicine / AIDS Program — New Haven, Connecticut, United States
- Rush Presbyterian - Saint Luke's Med Ctr / Infect Dis — Chicago, Illinois, United States
- Johns Hopkins Hosp — Baltimore, Maryland, United States
- Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States
- Brigham and Women's Hosp — Boston, Massachusetts, United States
- Fenway Community Health Ctr — Boston, Massachusetts, United States
- Beth Israel Deaconess Med Ctr - East Campus — Boston, Massachusetts, United States
- NYU Med Ctr — New York, New York, United States
- Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit — Stony Brook, New York, United States
- Pitt Treatment Ctr — Pittsburgh, Pennsylvania, United States
- Brown Univ / Miriam Hosp — Providence, Rhode Island, United States
- Saint Paul's Hosp — Vancouver, British Columbia, Canada
- Montreal Gen Hosp — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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