A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00002424 |
Recruitment Status
:
Suspended
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: L-756423 Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 186 participants |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Double-Blind, Randomized Pilot Study to Compare the Safety and Activity of L-756423/Indinavir, 1600/800 Mg Qd or 800/400 Mg Bid Versus Indinavir, 800 Mg q8h, All in Combination With Stavudine and Lamivudine |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this trial if you:
- Have HIV infection.
- Have levels of CD4 cells of 100 cells/mm3 or greater.
- Have a viral load of 10,000 copies/ml or greater.
- Are 18 years of age or older.
Exclusion Criteria
You may not be eligible for this trial if you:
- Have ever taken anti-HIV drugs.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002424
United States, California | |
UCLA School of Medicine / Ctr for Research and Education | |
Los Angeles, California, United States, 900951793 | |
United States, District of Columbia | |
Georgetown Univ Med Ctr | |
Washington, District of Columbia, United States, 20007 | |
ViRx / Dupont Circle Physicians Group | |
Washington, District of Columbia, United States, 20009 | |
United States, Florida | |
Associates in Research | |
Fort Myers, Florida, United States, 33901 | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 33136 | |
United States, Georgia | |
Grady Mem Hosp | |
Atlanta, Georgia, United States, 30308 | |
United States, Illinois | |
Rush Presbyterian - Saint Luke's Med Ctr | |
Chicago, Illinois, United States, 60612 | |
The CORE Ctr | |
Chicago, Illinois, United States, 60612 | |
United States, Kentucky | |
Univ of Kentucky Med Ctr | |
Lexington, Kentucky, United States, 40536 | |
Univ of Kentucky | |
Lexington, Kentucky, United States, 40536 | |
United States, Massachusetts | |
Beth Israel Deaconess Med Ctr | |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Henry Ford Hosp | |
Detroit, Michigan, United States, 48202 | |
United States, New York | |
NYU Med Ctr / C & D Building | |
New York, New York, United States, 10016 | |
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ | |
New York, New York, United States, 10021 | |
SUNY at Stony Brook / Div of Infectious Disease | |
Stony Brook, New York, United States, 117948153 | |
United States, Rhode Island | |
The Miriam Hosp | |
Providence, Rhode Island, United States, 02906 |
ClinicalTrials.gov Identifier: | NCT00002424 History of Changes |
Other Study ID Numbers: |
300B 009-01 009-00 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | April 2000 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination Drug Administration Schedule Stavudine HIV Protease Inhibitors |
Lamivudine Indinavir Reverse Transcriptase Inhibitors Anti-HIV Agents |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lamivudine Stavudine Indinavir |
Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Antimetabolites HIV Protease Inhibitors Protease Inhibitors |