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| Sponsored by: |
Dupont Merck |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002393 |
Purpose
The purpose of this study is to see if it is safe and effective to add DMP 266 to an anti-HIV treatment program of indinavir and nucleoside reverse transcriptase inhibitors (NRTIs).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Efavirenz |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Efficacy Study |
| Official Title: | A Phase III, Double-Blind, Placebo-Controlled, Multicenter Study to Determine the Effectiveness and Tolerability of the Combination of DMP 266 and Indinavir Versus Indinavir in HIV-Infected Patients Receiving Nucleoside Analogue (NRTI) Therapy |
| Estimated Enrollment: | 300 |
In this double-blind, placebo-controlled study, 300 patients are randomized to 1 or 2 reverse transcriptase inhibitors of their choice plus blinded therapy on Arm A or B as follows: Arm A: DMP 266 placebo plus indinavir. Arm B: DMP 266 plus indinavir. After 16 weeks, patients may switch the NRTI portion of their regimen if they meet a treatment failure criterion.
After the completion of the 24-week period, patients have the option to continue on open-label DMP 266 and indinavir.
Eligibility| Ages Eligible for Study: | 13 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Prior Medication:
Excluded:
Required:
One or two NRTIs (except ZDV and d4T in combination) for a minimum of 8 weeks, within 12 weeks prior to screening.
Contacts and Locations| United States, California | |
| Kaiser Foundation Hospital | |
| San Francisco, California, United States, 94118 | |
| United States, Georgia | |
| Med College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| Chicago Ctr for Clinical Research | |
| Chicago, Illinois, United States, 60610 | |
| United States, Kentucky | |
| Univ of Kentucky Med Ctr / Chandler Med Ctr | |
| Lexington, Kentucky, United States, 405360084 | |
| United States, Louisiana | |
| Tulane Univ / Tulane / LSU Clinical Trials Unit | |
| New Orleans, Louisiana, United States, 70122 | |
| United States, New York | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Univ of Rochester Med Ctr | |
| Rochester, New York, United States, 14642 | |
| United States, Tennessee | |
| Vanderbilt Univ | |
| Nashville, Tennessee, United States, 372321302 | |
| United States, Virginia | |
| Hampton Roads Med Specialists | |
| Hampton, Virginia, United States, 23666 | |
| Canada, Alberta | |
| Southern Alberta HIV Clinic / Foot Hills Hosp | |
| Calgary, Alberta, Canada | |
| Canada, Ontario | |
| Ottawa Gen Hosp | |
| Ottawa, Ontario, Canada | |
| Puerto Rico | |
| Univ of Puerto Rico School of Medicine | |
| San Juan, Puerto Rico, 00927 | |
More Information
| Study ID Numbers: | 281A, DMP 266-020 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002393 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Placebos Drug Therapy, Combination HIV Protease Inhibitors |
Indinavir Reverse Transcriptase Inhibitors efavirenz |
|
Anti-Infective Agents Efavirenz Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Indinavir Acquired Immunodeficiency Syndrome Antiviral Agents |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Indinavir Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors Efavirenz RNA Virus Infections |
HIV Protease Inhibitors 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 |
