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Home > "A" Clinical Trials Conditions > A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations  A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations
A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations
For Condition: HIV Infections
Status: Completed
Sponsor(s): Merck ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 220
Location and Contact Information:
Denver Public Health Dept
Denver, Colorado, 80204
United States
The Research and Education Group
Portland, Oregon, 97210
United States
Institute of Human Virology
Baltimore, Maryland, 21201
United States
Univ of Alabama School of Med
Montgomery, Alabama, 36116
United States
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114
United States
Infections Ltd / Physicians Med Ctr
Tacoma, Washington, 98405
United States
AIDS Healthcare Foundation
Los Angeles, California, 90027
United States
Oasis Clinic / King Drew Med Ctr
Los Angeles, California, 90059
United States
Education & Research Building
Camden, New Jersey, 08103
United States
Harold Katner MD
Macon, Georgia, 31202
United States
Brookdale Univ Hosp and Med Ctr
Brooklyn, New York, 112123198
United States
Univ TX Galveston Med Branch
Galveston, Texas, 77555
United States
Robert Scott MD
Oakland, California, 94609
United States
AIDS Consultation Service / Maine Med Ctr
Portland, Maine, 04102
United States
JSI Research and Training Institute
Boston, Massachusetts, 02210
United States
Fanno Creek Clinic
Portland, Oregon, 97219
United States
Anderson Clinical Research / Inc
Pittsburgh, Pennsylvania, 15213
United States
Univ of Illinois
Chicago, Illinois, 60612
United States
IDC Research Initiative
Altamonte Springs, Florida, 32701
United States
Blick Med Associates
Stamford, Connecticut, 06901
United States
Pacific Horizons Med Group
San Francisco, California, 94115
United States
Kentucky Clinical Research
Lexington, Kentucky, 40504
United States
Tower ID Med Associates
Los Angeles, California, 90048
United States
AIDS Community Research Consortium
Redwood City, California, 94063
United States
NJCRI
Newark, New Jersey, 07103
United States
Burnside Clinic
Columbia, South Carolina, 29206
United States
Emory Univ
Atlanta, Georgia, 30308
United States
Community Health Network
Rochester, New York, 14620
United States
Thomas Coffman MD
Boise, Idaho, 83712
United States
James Jones MD
New York City, New York, 10019
United States
Oak Lawn Physicians Group
Dallas, Texas, 75219
United States
Harbor - UCLA Med Ctr
Torrance, California, 90502
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
United States
Kaiser Foundation Hospital
San Francisco, California, 94118
United States
Wake Forest Univ School of Medicine
Winston Salem, North Carolina, 27157
United States
Hillsborough County Health Dept
Tampa, Florida, 33602
United States
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610
United States
Liberty Med Group
New York City, New York, 10016
United States
Infectious Disease Specialists of NJ
Union, New Jersey, 07083
United States
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, 94109
United States
Ocean View Internal Medicine
Long Beach, California, 90803
United States
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
Physicans Home Service
Washington D.C., District of Columbia, 20037
United States
Northwestern Univ Med Ctr
Chicago, Illinois, 60611
United States
Additional Information:
Study ID Numbers: 246R; 079-02,CRX454
Study Start Date:
Record last reviewed: February 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002430
Other Hiv Infections Studies:
1. A Multi-Center Clinical Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS Post First Episode PCP
2. A Study of Two Anti-HIV Drug Combinations
3. A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection.
4. Safety of and Immune Response to an HIV Vaccine (SF-2 gp120) With or Without MTP-PE/MF59 Adjuvant
5. Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers
Related Studies:
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A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations
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