The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients With No Symptoms of Infection
A Multiclinic, Open Study to Evaluate the Ability of the Combination of Indinavir, Zidovudine and Lamivudine to Result in Sustained Suppression of HIV-1 in Asymptomatic HIV-1 Seropositive Patients
2 other identifiers
interventional
200
2 countries
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hiv-infections
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
June 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Univ of Alabama at Birmingham
Birmingham, Alabama, 352942050, United States
LAC - USC Med Ctr
Los Angeles, California, 90033, United States
AIDS Community Research Consortium
Redwood City, California, 94063, United States
San Francisco Gen Hosp
San Francisco, California, 94110, United States
Yale Univ School of Medicine / AIDS Program
New Haven, Connecticut, 06510, United States
Rush Presbyterian - Saint Luke's Med Ctr / Infect Dis
Chicago, Illinois, 606123832, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
Brigham and Women's Hosp
Boston, Massachusetts, 02115, United States
Fenway Community Health Ctr
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Med Ctr - East Campus
Boston, Massachusetts, 02215, United States
NYU Med Ctr
New York, New York, 10016, United States
Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit
Stony Brook, New York, 117948153, United States
Pitt Treatment Ctr
Pittsburgh, Pennsylvania, 15213, United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906, United States
Saint Paul's Hosp
Vancouver, British Columbia, Canada
Montreal Gen Hosp
Montreal, Quebec, Canada