|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | 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 |
| 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 | |
More Information
| Study ID Numbers: | 264D, PROA3001 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002195 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Zidovudine HIV Protease Inhibitors Lamivudine |
VX 478 Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
|
Antimetabolites Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Bacterial Agents Amprenavir Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Antibiotics, Antitubercular Virus Diseases HIV Infections Sexually Transmitted Diseases |