A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations

HIV Infections Clinical Trial

Official title:

A Multicenter, Open-Label, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate/d4T/3TC Versus Indinavir Sulfate/Nelfinavir Mesylate/d4T/3TC in HIV-Infected Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002430
• Other study ID #: 246R
• Secondary ID: 079-02CRX454
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: February 2000
• 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 two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied.

Description:

Patients are stratified by screening plasma viral RNA results (50,000 copies/ml or below vs above 50,000 copies/ml) and randomized to 1 of 2 treatment arms. Group 1 receives IDV 3 times daily plus d4T/3TC twice daily. Group 2 receives IDV/NFV/d4T/3TC twice daily. Patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study. At each clinic visit, blood samples are taken to evaluate CD4 cell count and plasma HIV RNA levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV positive.

• Have a viral load (level of HIV in your blood) of at least 10,000 copies/ml within 45 days of study entry.

• Have a CD4 cell count of at least 100 cells/mm3 within 45 days of study entry.

• Have a normal chest X-ray.

• Have never taken protease inhibitors or 3TC.

• Are 16 years of age or older.

• Agree to practice sexual abstinence or use barrier methods of birth control (e.g., condoms).

Exclusion Criteria

You will not be eligible for this study if you:

• Have an active opportunistic (AIDS-related) infection or cancer.

• Have certain types of Kaposi's sarcoma.

• Have hepatitis.

• Have chronic diarrhea.

• Have a history of certain medical conditions.

• Are allergic to any of the study medications.

• Are taking certain medications.

• Are pregnant or breast-feeding.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Indinavir sulfate

• Nelfinavir mesylate

• Lamivudine

• Stavudine

Locations

Country	Name	City	State
United States	IDC Research Initiative	Altamonte Springs	Florida
United States	Emory Univ	Atlanta	Georgia
United States	Institute of Human Virology	Baltimore	Maryland
United States	Thomas Coffman MD	Boise	Idaho
United States	JSI Research and Training Institute	Boston	Massachusetts
United States	Brookdale Univ Hosp and Med Ctr	Brooklyn	New York
United States	Education & Research Building	Camden	New Jersey
United States	Chicago Ctr for Clinical Research	Chicago	Illinois
United States	Northwestern Univ Med Ctr	Chicago	Illinois
United States	Univ of Illinois	Chicago	Illinois
United States	Burnside Clinic	Columbia	South Carolina
United States	Oak Lawn Physicians Group	Dallas	Texas
United States	Denver Public Health Dept	Denver	Colorado
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Kentucky Clinical Research	Lexington	Kentucky
United States	Ocean View Internal Medicine	Long Beach	California
United States	AIDS Healthcare Foundation	Los Angeles	California
United States	Oasis Clinic / King Drew Med Ctr	Los Angeles	California
United States	Tower ID Med Associates	Los Angeles	California
United States	Harold Katner MD	Macon	Georgia
United States	Univ of Miami School of Medicine	Miami	Florida
United States	Univ of Alabama School of Med	Montgomery	Alabama
United States	Vanderbilt Univ Med Ctr	Nashville	Tennessee
United States	Louisiana State Univ Med Ctr / Tulane Med School	New Orleans	Louisiana
United States	James Jones MD	New York	New York
United States	Liberty Med Group	New York	New York
United States	Mount Sinai Med Ctr	New York	New York
United States	NJCRI	Newark	New Jersey
United States	Robert Scott MD	Oakland	California
United States	Anderson Clinical Research / Inc	Pittsburgh	Pennsylvania
United States	AIDS Consultation Service / Maine Med Ctr	Portland	Maine
United States	Fanno Creek Clinic	Portland	Oregon
United States	The Research and Education Group	Portland	Oregon
United States	AIDS Community Research Consortium	Redwood City	California
United States	Community Health Network	Rochester	New York
United States	Kaiser Foundation Hospital	San Francisco	California
United States	Pacific Horizons Med Group	San Francisco	California
United States	Saint Francis Mem Hosp / HIV Care Unit	San Francisco	California
United States	Blick Med Associates	Stamford	Connecticut
United States	Infections Ltd / Physicians Med Ctr	Tacoma	Washington
United States	Hillsborough County Health Dept	Tampa	Florida
United States	Harbor - UCLA Med Ctr	Torrance	California
United States	Associates in Med and Mental Health	Tulsa	Oklahoma
United States	Infectious Disease Specialists of NJ	Union	New Jersey
United States	Physicans Home Service	Washington	District of Columbia
United States	Wake Forest Univ School of Medicine	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States,