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

Condition(s) targeted: HIV Infections

Intervention: Indinavir sulfate (Drug); Nelfinavir mesylate (Drug); Lamivudine (Drug); Stavudine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Merck

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.

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

Study design: Treatment, Safety Study

Detailed 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.

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Univ of Alabama School of Med, Montgomery, Alabama 36116, United States

AIDS Community Research Consortium, Redwood City, California 94063, United States

Harbor - UCLA Med Ctr, Torrance, California 90502, United States

Pacific Horizons Med Group, San Francisco, California 94115, United States

Robert Scott MD, Oakland, California 94609, United States

Saint Francis Mem Hosp / HIV Care Unit, San Francisco, California 94109, United States

Kaiser Foundation Hospital, San Francisco, California 94118, United States

Tower ID Med Associates, Los Angeles, California 90048, United States

AIDS Healthcare Foundation, Los Angeles, California 90027, United States

Oasis Clinic / King Drew Med Ctr, Los Angeles, California 90059, United States

Ocean View Internal Medicine, Long Beach, California 90803, United States

Denver Public Health Dept, Denver, Colorado 80204, United States

Blick Med Associates, Stamford, Connecticut 06901, United States

Physicans Home Service, Washington, District of Columbia 20037, United States

IDC Research Initiative, Altamonte Springs, Florida 32701, United States

Univ of Miami School of Medicine, Miami, Florida 33136, United States

Hillsborough County Health Dept, Tampa, Florida 33602, United States

Emory Univ, Atlanta, Georgia 30308, United States

Harold Katner MD, Macon, Georgia 31202, United States

Thomas Coffman MD, Boise, Idaho 83712, United States

Northwestern Univ Med Ctr, Chicago, Illinois 60611, United States

Univ of Illinois, Chicago, Illinois 60612, United States

Chicago Ctr for Clinical Research, Chicago, Illinois 60610, United States

Kentucky Clinical Research, Lexington, Kentucky 40504, United States

Louisiana State Univ Med Ctr / Tulane Med School, New Orleans, Louisiana 70112, United States

AIDS Consultation Service / Maine Med Ctr, Portland, Maine 04102, United States

Institute of Human Virology, Baltimore, Maryland 21201, United States

JSI Research and Training Institute, Boston, Massachusetts 02210, United States

Education & Research Building, Camden, New Jersey 08103, United States

NJCRI, Newark, New Jersey 07103, United States

Infectious Disease Specialists of NJ, Union, New Jersey 07083, United States

Mount Sinai Med Ctr, New York, New York 10029, United States

Community Health Network, Rochester, New York 14620, United States

Liberty Med Group, New York, New York 10016, United States

Brookdale Univ Hosp and Med Ctr, Brooklyn, New York 112123198, United States

James Jones MD, New York, New York 10019, United States

Wake Forest Univ School of Medicine, Winston Salem, North Carolina 27157, United States

Associates in Med and Mental Health, Tulsa, Oklahoma 74114, United States

The Research and Education Group, Portland, Oregon 97210, United States

Fanno Creek Clinic, Portland, Oregon 97219, United States

Anderson Clinical Research / Inc, Pittsburgh, Pennsylvania 15213, United States

Burnside Clinic, Columbia, South Carolina 29206, United States

Vanderbilt Univ Med Ctr, Nashville, Tennessee 37203, United States

Oak Lawn Physicians Group, Dallas, Texas 75219, United States

Univ TX Galveston Med Branch, Galveston, Texas 77555, United States

Infections Ltd / Physicians Med Ctr, Tacoma, Washington 98405, United States

Last updated: June 23, 2005