The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002387
• Other study ID #: 246K
• Secondary ID: 067-00
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Indinavir sulfate

• Efavirenz

Locations

Country	Name	City	State
United States	Beth Israel Hosp	Boston	Massachusetts
United States	Rush Med Ctr / Section of Infectious Diseases	Chicago	Illinois
United States	Univ of Colorado / Health Science Ctr	Denver	Colorado
United States	Hawaii AIDS Clinical Trial Unit	Honolulu	Hawaii
United States	Brown Univ / Miriam Hosp	Providence	Rhode Island
United States	UCSD Treatment Ctr / Dept of Medicine & Pediatrics	San Diego	California
United States	San Francisco Gen Hosp	San Francisco	California
United States	Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States,