Clinical trial NCT00002387: The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
Drug Administration Schedule
HIV Protease Inhibitors
Indinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
efavirenz
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Treatment Ctr / Dept of Medicine & Pediatrics
state: California
city: San Francisco
country: United States
facility: San Francisco Gen Hosp
state: California
city: Denver
country: United States
facility: Univ of Colorado / Health Science Ctr
state: Colorado
city: Honolulu
country: United States
facility: Hawaii AIDS Clinical Trial Unit
state: Hawaii
city: Chicago
country: United States
facility: Rush Med Ctr / Section of Infectious Diseases
state: Illinois
city: Boston
country: United States
facility: Beth Israel Hosp
state: Massachusetts
city: Stony Brook
country: United States
facility: Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit
state: New York
city: Providence
country: United States
facility: Brown Univ / Miriam Hosp
state: Rhode Island
Study officials:
References: