A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00002195 |
Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Amprenavir Drug: Lamivudine Drug: Zidovudine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 290 participants |
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. |

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002195
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 |
ClinicalTrials.gov Identifier: | NCT00002195 |
Other Study ID Numbers: |
264D PROA3001 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | November 1998 |
Drug Therapy, Combination Zidovudine HIV Protease Inhibitors Lamivudine |
VX 478 Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
Infections HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lamivudine |
Zidovudine Amprenavir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents Antimetabolites Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents HIV Protease Inhibitors |