A Study of Indinavir Taken With or Without DMP 266

HIV Infections Clinical Trial

Official title:

A Phase III, Double-Blind, Placebo-Controlled, Multicenter Study to Determine the Effectiveness and Tolerability of the Combination of DMP 266 and Indinavir Versus Indinavir in HIV-Infected Patients Receiving Nucleoside Analogue (NRTI) Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002393
• Other study ID #: 281A
• Secondary ID: DMP 266-020
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: July 1998
• 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

The purpose of this study is to see if it is safe and effective to add DMP 266 to an anti-HIV treatment program of indinavir and nucleoside reverse transcriptase inhibitors (NRTIs).

Description:

In this double-blind, placebo-controlled study, 300 patients are randomized to 1 or 2 reverse transcriptase inhibitors of their choice plus blinded therapy on Arm A or B as follows:

Arm A: DMP 266 placebo plus indinavir. Arm B: DMP 266 plus indinavir. After 16 weeks, patients may switch the NRTI portion of their regimen if they meet a treatment failure criterion. After the completion of the 24-week period, patients have the option to continue on open-label DMP 266 and indinavir.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 60 Years

Eligibility

Inclusion Criteria

Patients must have:

• CD4+ cell count of at least 50 cells/mm3.

• HIV RNA level of at least 10,000 copies/ml by reverse transcriptase polymerase chain reaction (RT-PCR, Amplicor test kit) at screening.

• Signed, informed consent from parent or legal guardian for patients less than 18 years of age.

Exclusion Criteria

Prior Medication:

Excluded:

• DMP 266.

• Other nonnucleoside reverse transcriptase inhibitors.

Required:

One or two NRTIs (except ZDV and d4T in combination) for a minimum of 8 weeks, within 12 weeks prior to screening.

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Indinavir sulfate

• Efavirenz

Locations

Country	Name	City	State
Canada	Southern Alberta HIV Clinic / Foot Hills Hosp	Calgary	Alberta
Canada	Ottawa Gen Hosp	Ottawa	Ontario
Puerto Rico	Univ of Puerto Rico School of Medicine	San Juan
United States	Med College of Georgia	Augusta	Georgia
United States	Chicago Ctr for Clinical Research	Chicago	Illinois
United States	Hampton Roads Med Specialists	Hampton	Virginia
United States	Univ of Kentucky Med Ctr / Chandler Med Ctr	Lexington	Kentucky
United States	Vanderbilt Univ	Nashville	Tennessee
United States	Tulane Univ / Tulane / LSU Clinical Trials Unit	New Orleans	Louisiana
United States	Mount Sinai Med Ctr	New York	New York
United States	Univ of Rochester Med Ctr	Rochester	New York
United States	Kaiser Foundation Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Dupont Merck

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

References & Publications (1)

Haas DW, Fessel WJ, Delapenha RA, Kessler H, Seekins D, Kaplan M, Ruiz NM, Ploughman LM, Labriola DF, Manion DJ. Therapy with efavirenz plus indinavir in patients with extensive prior nucleoside reverse-transcriptase inhibitor experience: a randomized, double-blind, placebo-controlled trial. J Infect Dis. 2001 Feb 1;183(3):392-400. Epub 2000 Dec 29. — View Citation