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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 Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients with HIV-Associated Kidney Disease

2. Phase I Safety and Immunogenicity Trial of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (gp160; VaxSyn)

3. A Study of Treatments for Fungal Infections of the Mouth and Throat in HIV-Infected Patients Who Have Had Success with Itraconazole But Not with Fluconazole

4. Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis carinii Pneumonia Prophylaxis

5. A Study to Demonstrate that Anti-HIV Drug Therapy can be Stopped Without Causing Viral Resistance, and to Characterize Drug Elimination from the Body

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

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