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| Sponsored by: |
Glaxo Wellcome |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002195 |
Purpose
The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.
| Condition | Intervention | Phase |
|
HIV Infections |
Drug: Amprenavir Drug: Lamivudine Drug: Zidovudine |
Phase III |
| MedlinePlus related topics: | AIDS |
| Drug Information available for: | Zidovudine Lamivudine VX 478 |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety Study |
| Official Title: | A Phase III Trial to Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination With Retrovir and Epivir Compared to Retrovir and Epivir Alone in Patients With HIV Infection. |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Clinical diagnosis of AIDS (CDC 1993 Classification C).
Concurrent Medication:
Excluded:
Terfenadine, astemizole, cisapride, triazolam, medazolam, and ergotamine/dihydroergotamine-containing regimens.
Patients with the following prior conditions are excluded:
Clinically relevant hepatitis in the previous 6 months.
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Radiotherapy within 4 weeks prior to entry.
Risk Behavior:
Excluded:
Current alcohol or illicit drug use that may interfere with the patient's ability to comply with the dosing schedule or protocol evaluations.
Contacts and Locations| United States, California | |||||
| Pacific Oaks Research | |||||
| Beverly Hills, California, United States, 90211 | |||||
| United States, District of Columbia | |||||
| Dr Bruce Rashbaum | |||||
| Washington, District of Columbia, United States, 20037 | |||||
| United States, Florida | |||||
| Community Research Initiative of Central Florida | |||||
| Maitland, Florida, United States, 32751 | |||||
| Univ of Miami School of Medicine | |||||
| Miami, Florida, United States, 33136 | |||||
| Community Research Initiative of South Florida | |||||
| Coral Gables, Florida, United States, 33146 | |||||
| United States, Illinois | |||||
| Chicago Ctr for Clinical Research | |||||
| Chicago, Illinois, United States, 60610 | |||||
| United States, Massachusetts | |||||
| Community Research Initiative of New England | |||||
| Brookline, Massachusetts, United States, 02445 | |||||
| United States, New York | |||||
| Saint Vincent's AIDS Ctr | |||||
| New York, New York, United States, 10011 | |||||
| United States, Tennessee | |||||
| Methodist Hosp | |||||
| Memphis, Tennessee, United States, 38104 | |||||
| Glaxo Wellcome |
More Information
| Study ID Numbers: | 264D, PROA3001 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002195 |
| Health Authority: | United States: Food and Drug Administration |
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