|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002440 |
Purpose
The purpose of this study is to see if it is safe and effective to give 1592U89 plus certain protease inhibitors (PIs) to HIV-infected patients who never have been treated with anti-HIV drugs. This study also examines how the body processes these drugs when they are given together.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Ritonavir Drug: Abacavir sulfate Drug: Amprenavir Drug: Nelfinavir mesylate Drug: Saquinavir |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | An Open-Label, Phase II Trial to Evaluate the Steady-State Pharmacokinetics, Safety, and Efficacy of 1592U89 in Combination With Selected HIV-1 Protease Inhibitors in Antiretroviral-Naive, HIV-1-Infected Patients. |
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Local treatment for Kaposi's sarcoma.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Radiation therapy within the first 24 weeks of study.
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Radiation therapy within 30 days of study drug administration. Alcohol or illicit drug use that may interfere with patient compliance.
Contacts and Locations| United States, California | |
| UCSD Treatment Ctr | |
| San Diego, California, United States, 921036329 | |
| United States, Connecticut | |
| Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit | |
| New Haven, Connecticut, United States, 065102483 | |
| United States, Missouri | |
| Kansas City AIDS Research Consortium | |
| Kansas City, Missouri, United States, 64111 | |
| United States, New York | |
| NYU Med Ctr / Dept of Medicine / AIDS Clinical Trial | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Carolinas Med Ctr | |
| Charlotte, North Carolina, United States, 28232 | |
| United States, Ohio | |
| Case Western Reserve Univ / AIDS Clinical Trials Unit | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| Univ of Pittsburgh Med Ctr | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| Vanderbilt Univ Med Ctr | |
| Nashville, Tennessee, United States, 372321302 | |
More Information
| Study ID Numbers: | 238J, CNAA2004 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002440 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Drug Therapy, Combination HIV Protease Inhibitors Mutation HIV-1 Reverse Transcriptase |
HIV Protease Reverse Transcriptase Inhibitors Anti-HIV Agents abacavir |
|
HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Indinavir Saquinavir Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors Reverse Transcriptase Inhibitors Virus Diseases |
Anti-Bacterial Agents Amprenavir Anti-Retroviral Agents HIV Infections Ritonavir Sexually Transmitted Diseases Antitubercular Agents Abacavir Nelfinavir Retroviridae Infections |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Indinavir Molecular Mechanisms of Pharmacological Action Saquinavir Infection Reverse Transcriptase Inhibitors Anti-Bacterial Agents Amprenavir Anti-Retroviral Agents Therapeutic Uses Nelfinavir Abacavir Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors RNA Virus Infections HIV Protease Inhibitors Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Antibiotics, Antitubercular Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases |