A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients
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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 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| 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:
- HIV-positive status.
- Screening viral load >= 10,000 copies/mm3 14 days prior to entry.
- CD4+ cell counts >= 200 cells/mm3 14 days prior to entry.
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:
- Greater than 4 weeks of any nucleoside antiretroviral therapy.
- Previous therapy with an HIV protease inhibitor.
- Cytotoxic chemotherapeutic agents within 4 weeks prior to entry.
- Immunomodulating agents within 3 months prior to entry.
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 South Florida | |
| Coral Gables, Florida, United States, 33146 | |
| Community Research Initiative of Central Florida | |
| Maitland, Florida, United States, 32751 | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| 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 | |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002195 History of Changes |
| Other Study ID Numbers: | 264D, PROA3001 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Drug Therapy, Combination Zidovudine HIV Protease Inhibitors Lamivudine |
VX 478 Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Lamivudine Reverse Transcriptase Inhibitors Amprenavir |
HIV Protease Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents Protease Inhibitors Antibiotics, Antitubercular Anti-Bacterial Agents Antitubercular Agents |
ClinicalTrials.gov processed this record on May 23, 2013