The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz
NCT ID: NCT00002387
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
NA
80 participants
INTERVENTIONAL
Brief Summary
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It is hypothesized that after 16 weeks of randomized treatment with either the control or experimental regimen that:
1. The observed proportion of patients with serum viral RNA \< 400 copies/ml in the experimental and control regimen will be similar and will continue to be so after 48 weeks.
2. The safety profiles of the two groups will be similar, judged by the incidence of serious, drug-related adverse experiences and the incidence of events of specific interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and CNS-related symptoms) and will continue to be so after 48 weeks.
3. The two groups will be similar with respect to changes from baseline in serum viral RNA and CD4 counts and will continue to be so after 48 weeks.
Detailed Description
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1. The observed proportion of patients with serum viral RNA \< 400 copies/ml in the experimental and control regimen will be similar and will continue to be so after 48 weeks.
2. The safety profiles of the two groups will be similar, judged by the incidence of serious, drug-related adverse experiences and the incidence of events of specific interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and CNS-related symptoms) and will continue to be so after 48 weeks.
3. The two groups will be similar with respect to changes from baseline in serum viral RNA and CD4 counts and will continue to be so after 48 weeks.
Patients are randomized to one of two regimens: a control regimen of indinavir plus DMP 266 or an experimental regimen of indinavir plus DMP 266, each at different doses than in the control regimen.
Conditions
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Study Design
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PARALLEL
TREATMENT
Interventions
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Indinavir sulfate
Efavirenz
Eligibility Criteria
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Inclusion Criteria
* HIV-1 seropositive status.
* CD4 count \>= 100 cells/mm3.
* Serum viral RNA levels \>= 10,000 copies/ml.
Exclusion Criteria
Excluded:
* Prior protease inhibitor therapy.
* Prior non-nucleoside reverse transcriptase inhibitor therapy.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Locations
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UCSD Treatment Ctr / Dept of Medicine & Pediatrics
San Diego, California, United States
San Francisco Gen Hosp
San Francisco, California, United States
Univ of Colorado / Health Science Ctr
Denver, Colorado, United States
Hawaii AIDS Clinical Trial Unit
Honolulu, Hawaii, United States
Rush Med Ctr / Section of Infectious Diseases
Chicago, Illinois, United States
Beth Israel Hosp
Boston, Massachusetts, United States
Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit
Stony Brook, New York, United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, United States
Countries
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Other Identifiers
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067-00
Identifier Type: -
Identifier Source: secondary_id
246K
Identifier Type: -
Identifier Source: org_study_id