A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine
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| ClinicalTrials.gov Identifier: NCT00002424 |
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Recruitment Status :
Suspended
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by:
NIH AIDS Clinical Trials Information Service
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Brief Summary:
This study will see how safe and effective against HIV the drugs L-756423 plus indinavir (IDV) are compared to just IDV when taken with stavudine (d4T) and lamivudine (3TC). The study will also see whether taking 1 large dose of L-756423/IDV once a day is as safe and effective as taking 2 smaller doses twice a day.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: L-756423 Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine | Phase 2 |
Patients are randomized to 1 of 4 treatment arms. In Group 1, patients receive a dose of L-756423/IDV once daily plus IDV placebo. In Group 3, patients receive a lower dose of L-756423/IDV twice daily (with the daily dosage equaling that of Group 1) plus IDV placebo. In Groups 2 and 4, patients receive equal dosages of IDV plus L-756423/IDV placebo. In all 4 groups L-756423 and IDV are blinded to the investigator and patient. All groups receive open-label d4T and 3TC. Patients routinely undergo a physical exam and have blood and urine tests to ensure the drugs' safety and tolerability, which will be evaluated by tabulation of adverse events and clinical assessment of laboratory data. In addition, CD4+ T cell and plasma viral RNA levels are measured to quantify the drugs' antiretroviral activity.
| 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 |
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
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
Locations
| 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 | |
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
| 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:
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Drug Therapy, Combination Drug Administration Schedule Stavudine HIV Protease Inhibitors |
Lamivudine Indinavir Reverse Transcriptase Inhibitors Anti-HIV Agents |
Additional relevant MeSH terms:
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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 |