Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir

HIV Infections Clinical Trial

Official title:

Multi-Center, Open-Label Study of the Effect of Indinavir, Efavirenz, and Adefovir Dipivoxil Combination Therapy in Patients Who Have Failed Nelfinavir

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002220
• Other study ID #: 246N
• Secondary ID: 075-00
• Status: Completed
• Phase: Phase 3
• 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

The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor (PI). Effectiveness is measured by the number of patients who have a viral load (level of HIV in the blood) below 400 copies/ml after 48 weeks of treatment.

Description:

In this open-label, nonrandomized study, 120 HIV-infected patients are stratified into two groups: failed nelfinavir vs protease inhibitor-naive. All patients receive indinavir plus efavirenz plus adefovir dipivoxil plus and L-carnitine, orally. Plasma vRNA is measured every 4 weeks until Week 16, then every 8 weeks for the remainder of the 48-week study.

Other known NCT identifiers

• NCT00002242

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria

Patients must have:

• Serologically documented HIV infection.

• Baseline CD4 count greater than or equal to 50 cells and vRNA greater than or equal to 10,000 copies/ml.

• Parental consent for patients under 18.

Nelfinavir-Failure Group:

• Must have protease inhibitor experience solely with nelfinavir and be considered drug-adherent.

• Must be candidate for changing therapy because of virologic failure and be receiving nelfinavir at entry (at least 16 weeks of nelfinavir plus NRTI therapy with at least a 10-fold decline in vRNA due to nelfinavir therapy and a subsequent increase toward the patient's baseline vRNA of at least 10-fold).

Control Group:

• Must have received any combination of currently licensed nucleoside reverse transcriptase inhibitors for at least 16 weeks.

• Must be naive to efavirenz, adefovir dipivoxil, and other NRTI's.

Exclusion Criteria

Prior Medication:

Excluded:

Control group:

• Prior efavirenz, adefovir dipivoxil, or other non-nucleoside reverse transcriptase inhibitors.

Required:

Nelfinavir-failure patients:

• At least 16 weeks of nelfinavir.

Control group:

• At least 16 weeks of any combination of currently licensed nucleoside reverse transcriptase inhibitors.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Indinavir sulfate

• Efavirenz

• Levocarnitine

• Adefovir dipivoxil

Locations

Country	Name	City	State
United States	Johns Hopkins Hosp	Baltimore	Maryland
United States	Massachusetts Gen Hosp	Boston	Massachusetts
United States	Rush Presbyterian Saint Lukes Med Ctr	Chicago	Illinois
United States	Oaklawn Physicians Group	Dallas	Texas
United States	Hawaii AIDS Clinical Trial Unit	Honolulu	Hawaii
United States	LAC / USC Med Ctr / Infectious Diseases	Los Angeles	California
United States	Vanderbilt Clinic	Nashville	Tennessee
United States	Yale Univ / AIDS Clinical Trials Unit	New Haven	Connecticut
United States	Columbia Presbyterian Hosp	New York	New York
United States	AIDS TMT Unit / Univ Hosp	Stonybrook	New York
United States	Med Ctr of Delaware	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States,