Back to resultsA Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indinavir sulfate
Nelfinavir mesylate
Lamivudine
Stavudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Nelfinavir
Eligibility 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.
Sites / Locations
- Univ of Alabama School of Med
- Ocean View Internal Medicine
- AIDS Healthcare Foundation
- Tower ID Med Associates
- Oasis Clinic / King Drew Med Ctr
- Robert Scott MD
- AIDS Community Research Consortium
- Saint Francis Mem Hosp / HIV Care Unit
- Pacific Horizons Med Group
- Kaiser Foundation Hospital
- Harbor - UCLA Med Ctr
- Denver Public Health Dept
- Blick Med Associates
- Physicans Home Service
- IDC Research Initiative
- Univ of Miami School of Medicine
- Hillsborough County Health Dept
- Emory Univ
- Harold Katner MD
- Thomas Coffman MD
- Chicago Ctr for Clinical Research
- Northwestern Univ Med Ctr
- Univ of Illinois
- Kentucky Clinical Research
- Louisiana State Univ Med Ctr / Tulane Med School
- AIDS Consultation Service / Maine Med Ctr
- Institute of Human Virology
- JSI Research and Training Institute
- Education & Research Building
- NJCRI
- Infectious Disease Specialists of NJ
- Brookdale Univ Hosp and Med Ctr
- Liberty Med Group
- James Jones MD
- Mount Sinai Med Ctr
- Community Health Network
- Wake Forest Univ School of Medicine
- Associates in Med and Mental Health
- The Research and Education Group
- Fanno Creek Clinic
- Anderson Clinical Research / Inc
- Burnside Clinic
- Vanderbilt Univ Med Ctr
- Oak Lawn Physicians Group
- Univ TX Galveston Med Branch
- Infections Ltd / Physicians Med Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002430
First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00002430
Brief Title
A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations
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 Type
Interventional
2. Study Status
Record Verification Date
February 2000
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Nelfinavir
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
220 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Stavudine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Univ of Alabama School of Med
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36116
Country
United States
Facility Name
Ocean View Internal Medicine
City
Long Beach
State/Province
California
ZIP/Postal Code
90803
Country
United States
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Tower ID Med Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Oasis Clinic / King Drew Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Facility Name
Robert Scott MD
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
AIDS Community Research Consortium
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Saint Francis Mem Hosp / HIV Care Unit
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Pacific Horizons Med Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Foundation Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Harbor - UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Denver Public Health Dept
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Blick Med Associates
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06901
Country
United States
Facility Name
Physicans Home Service
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Hillsborough County Health Dept
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Emory Univ
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Harold Katner MD
City
Macon
State/Province
Georgia
ZIP/Postal Code
31202
Country
United States
Facility Name
Thomas Coffman MD
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Chicago Ctr for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Northwestern Univ Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Univ of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Kentucky Clinical Research
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Louisiana State Univ Med Ctr / Tulane Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
AIDS Consultation Service / Maine Med Ctr
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Institute of Human Virology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
JSI Research and Training Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02210
Country
United States
Facility Name
Education & Research Building
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
NJCRI
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Infectious Disease Specialists of NJ
City
Union
State/Province
New Jersey
ZIP/Postal Code
07083
Country
United States
Facility Name
Brookdale Univ Hosp and Med Ctr
City
Brooklyn
State/Province
New York
ZIP/Postal Code
112123198
Country
United States
Facility Name
Liberty Med Group
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
James Jones MD
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Community Health Network
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Wake Forest Univ School of Medicine
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Associates in Med and Mental Health
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
The Research and Education Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Fanno Creek Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97219
Country
United States
Facility Name
Anderson Clinical Research / Inc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Burnside Clinic
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29206
Country
United States
Facility Name
Vanderbilt Univ Med Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Oak Lawn Physicians Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Infections Ltd / Physicians Med Ctr
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations
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