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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002430
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 2000
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Indinavir sulfate
Drug: Nelfinavir mesylate
Drug: Lamivudine
Drug: Stavudine

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 220
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002430

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama School of Med
Montgomery, Alabama, United States, 36116
United States, California
Ocean View Internal Medicine
Long Beach, California, United States, 90803
Oasis Clinic / King Drew Med Ctr
Los Angeles, California, United States, 90059
AIDS Healthcare Foundation
Los Angeles, California, United States, 90027
Tower ID Med Associates
Los Angeles, California, United States, 90048
Robert Scott MD
Oakland, California, United States, 94609
AIDS Community Research Consortium
Redwood City, California, United States, 94063
Kaiser Foundation Hospital
San Francisco, California, United States, 94118
Pacific Horizons Med Group
San Francisco, California, United States, 94115
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, United States, 94109
Harbor - UCLA Med Ctr
Torrance, California, United States, 90502
United States, Colorado
Denver Public Health Dept
Denver, Colorado, United States, 80204
United States, Connecticut
Blick Med Associates
Stamford, Connecticut, United States, 06901
United States, District of Columbia
Physicans Home Service
Washington, District of Columbia, United States, 20037
United States, Florida
IDC Research Initiative
Altamonte Springs, Florida, United States, 32701
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
Hillsborough County Health Dept
Tampa, Florida, United States, 33602
United States, Georgia
Emory Univ
Atlanta, Georgia, United States, 30308
Harold Katner MD
Macon, Georgia, United States, 31202
United States, Idaho
Thomas Coffman MD
Boise, Idaho, United States, 83712
United States, Illinois
Univ of Illinois
Chicago, Illinois, United States, 60612
Chicago Ctr for Clinical Research
Chicago, Illinois, United States, 60610
Northwestern Univ Med Ctr
Chicago, Illinois, United States, 60611
United States, Kentucky
Kentucky Clinical Research
Lexington, Kentucky, United States, 40504
United States, Louisiana
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, United States, 70112
United States, Maine
AIDS Consultation Service / Maine Med Ctr
Portland, Maine, United States, 04102
United States, Maryland
Institute of Human Virology
Baltimore, Maryland, United States, 21201
United States, Massachusetts
JSI Research and Training Institute
Boston, Massachusetts, United States, 02210
United States, New Jersey
Education & Research Building
Camden, New Jersey, United States, 08103
NJCRI
Newark, New Jersey, United States, 07103
Infectious Disease Specialists of NJ
Union, New Jersey, United States, 07083
United States, New York
Brookdale Univ Hosp and Med Ctr
Brooklyn, New York, United States, 112123198
Liberty Med Group
New York, New York, United States, 10016
Mount Sinai Med Ctr
New York, New York, United States, 10029
James Jones MD
New York, New York, United States, 10019
Community Health Network
Rochester, New York, United States, 14620
United States, North Carolina
Wake Forest Univ School of Medicine
Winston Salem, North Carolina, United States, 27157
United States, Oklahoma
Associates in Med and Mental Health
Tulsa, Oklahoma, United States, 74114
United States, Oregon
Fanno Creek Clinic
Portland, Oregon, United States, 97219
The Research and Education Group
Portland, Oregon, United States, 97210
United States, Pennsylvania
Anderson Clinical Research / Inc
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Burnside Clinic
Columbia, South Carolina, United States, 29206
United States, Tennessee
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States, 37203
United States, Texas
Oak Lawn Physicians Group
Dallas, Texas, United States, 75219
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77555
United States, Washington
Infections Ltd / Physicians Med Ctr
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002430     History of Changes
Other Study ID Numbers: 246R, 079-02, CRX454
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
HIV Protease Inhibitors
Lamivudine
Indinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Nelfinavir

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Indinavir
Lamivudine
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014