The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Indinavir sulfate (Drug); Efavirenz (Drug)
Phase: N/A
Status: Completed
Sponsored by: Merck
Summary
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.
Clinical Details
Official title: A Multicenter, Open, Randomized, Forty-Eight-Week, Pilot Study to Evaluate the Activity, Safety, and Pharmacokinetics of Indinavir Sulfate, 1200 Mg q 12h and DMP 266, 300 Mg q 12h Versus Indinavir Sulfate, 1000 Mg q 8h and DMP 266, 600 Mg q.h.s.
Study design: Treatment, Parallel Assignment, Safety Study
Detailed description:
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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Patients must have:
- HIV-1 seropositive status.
- CD4 count >= 100 cells/mm3.
- Serum viral RNA levels >= 10,000 copies/ml.
Exclusion Criteria
Prior Medication:
Excluded:
- Prior protease inhibitor therapy.
- Prior non-nucleoside reverse transcriptase inhibitor therapy.
Locations and Contacts
San Francisco Gen Hosp, San Francisco, California 94110, United States
UCSD Treatment Ctr / Dept of Medicine & Pediatrics, San Diego, California 921036329, United States
Univ of Colorado / Health Science Ctr, Denver, Colorado 80262, United States
Hawaii AIDS Clinical Trial Unit, Honolulu, Hawaii 96816, United States
Rush Med Ctr / Section of Infectious Diseases, Chicago, Illinois 60612, United States
Beth Israel Hosp, Boston, Massachusetts 02215, United States
Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit, Stony Brook, New York 117948153, United States
Brown Univ / Miriam Hosp, Providence, Rhode Island 02906, United States
Additional Information
Last updated: June 23, 2005
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