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| Sponsor: | Merck |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002424 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: L-756423 Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| 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 |
| Estimated Enrollment: | 186 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this trial if you:
Exclusion Criteria
You may not be eligible for this trial if you:
Contacts and 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 | |
| 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 | |
| NYU Med Ctr / C & D Building | |
| New York, New York, United States, 10016 | |
| United States, Rhode Island | |
| The Miriam Hosp | |
| Providence, Rhode Island, United States, 02906 | |
More Information
| Study ID Numbers: | 300B, 009-01, 009-00 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002424 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Drug Administration Schedule Stavudine HIV Protease Inhibitors |
Lamivudine Indinavir Reverse Transcriptase Inhibitors Anti-HIV Agents |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Stavudine Slow Virus Diseases Indinavir Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |
