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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 |
| MedlinePlus related topics: | AIDS |
| Drug Information available for: | Indinavir Indinavir Sulfate Efavirenz |
| 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 | |||||
| Dupont Merck |
More Information
| Study ID Numbers: | 281A, DMP 266-020 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002393 |
| Health Authority: | United States: Food and Drug Administration |
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