The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz
Completed · Not applicable
Conditions studied: HIV Infections
In brief
To estimate the differences in parameters of antiviral activity and safety between a control regimen of indinavir in combination with DMP 266 and an experimental regimen of higher-dose indinavir in combination with lower-dose DMP 266 after sixteen weeks of dosing, in protease inhibitor- and non-nucleoside reverse transcriptase inhibitor-naive, HIV-1 seropositive patients. 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.
Key facts
- Study ID
- NCT00002387
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 80
- 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 >= 100 cells/mm3.
- Serum viral RNA levels >= 10,000 copies/ml.
You may not qualify if…
- Prior Medication:
- Excluded:
- Prior protease inhibitor therapy.
- Prior non-nucleoside reverse transcriptase inhibitor therapy.
Where it is running
- 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
Full record on ClinicalTrials.gov
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