The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz
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.
2 other identifiers
interventional
80
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
8 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 \>= 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
UCSD Treatment Ctr / Dept of Medicine & Pediatrics
San Diego, California, 921036329, United States
San Francisco Gen Hosp
San Francisco, California, 94110, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1999-06