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| Sponsored by: |
Merck |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002452 |
Purpose
The purpose of this study is to see if L-756423, an anti-HIV drug, is safe to give with indinavir and if it works well at lowering the level of HIV in the blood (viral load).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: L-756423 Drug: Indinavir sulfate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Multicenter, Open-Label, Pilot Study to Evaluate the Safety and Activity of L-756423/Indinavir Sulfate, 800/400 Mg b.i.d. in Combination With Two nRTIs in HIV-Infected Patients Who Failed an Indinavir Containing Regimen |
| Estimated Enrollment: | 30 |
All patients receive L-756423 plus indinavir plus two licensed nucleoside reverse transcriptase inhibitors (NRTIs), at least one to which the patient is naive. Patients remain on the drug regimen for 12 weeks (with possible extension to 16 weeks). Patients are evaluated with physical examinations and laboratory tests for blood and urine at Weeks 1, 2, 4, 6, 8, and 12 and two weeks post study. Plasma viral RNA is measured at Weeks 1, 2, 4, 6, 8, and 12. CD4 cell counts are measured at Weeks 2,4,8, and 12.
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 study if you:
Exclusion Criteria
You will not be eligible for this study if you:
Contacts and Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 352942050 | |
| United States, District of Columbia | |
| Georgetown Univ | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Hawaii | |
| Hawaii AIDS Clinical Trial Unit | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Illinois | |
| The CORE Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, New York | |
| Cornell Clinical Trials Unit - Chelsea Clinic | |
| New York, New York, United States, 10011 | |
| United States, Pennsylvania | |
| Pittsburgh Treatment Ctr / Univ of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| United States, Tennessee | |
| Vanderbilt Univ Med Ctr | |
| Nashville, Tennessee, United States, 37203 | |
More Information
| Study ID Numbers: | 300A, 008-00 |
| Study First Received: | January 17, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002452 |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination HIV Protease Inhibitors Indinavir |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
|
Virus Diseases Sexually Transmitted Diseases, Viral Indinavir HIV Seropositivity HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
|
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |
