The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients With No Symptoms of Infection
NCT ID: NCT00002179
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
Brief Summary
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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.
Detailed Description
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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.
All patients receive indinavir plus zidovudine plus lamivudine for at least 96 weeks. If there is no evidence of infectious virus, and patients continue to have serum viral RNA levels below the limit of detection of the ultradirect assay for at least 96 weeks, therapy is continued for an additional 24 weeks. However, during this additional 24 weeks of therapy patients may continue to receive this triple combination drug regimen or make changes to this drug regimen treatment by reducing their number of antiretroviral agents. After 120 weeks, if patients continue to have serum viral RNA levels below the limit of detection of the ultradirect assay, patients discontinue all antiretroviral therapy. However, if there is any evidence of infectious virus, as outlined above, patients do not discontinue therapy. Patients who develop detectable serum viral RNA following discontinuation of therapy are given the option to reinitiate therapy with the triple combination of indinavir, zidovudine and lamivudine. NOTE: Patients who develop an intolerance to zidovudine may use stavudine at doses per body weight at the direction of the investigator.
Conditions
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Study Design
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TREATMENT
Interventions
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Indinavir sulfate
Lamivudine
Zidovudine
Eligibility Criteria
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Inclusion Criteria
* HIV-1 seropositive status.
* CD4 count \>= 500 cells/mm3.
* Serum viral RNA level \> 1000 copies/ml.
Exclusion Criteria
Excluded:
Previous antiretroviral therapy.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Locations
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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
Countries
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Other Identifiers
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MK-0639
Identifier Type: -
Identifier Source: secondary_id
246G
Identifier Type: -
Identifier Source: org_study_id