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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002233 |
Purpose
The purpose of this study is to see if it is safe to give a combination of four anti-HIV drugs to patients recently infected with HIV who have never received anti-HIV treatment. The effects of this combination of drugs on the immune system and the level of HIV in the body are studied also. The four-drug combination includes lamivudine, abacavir, amprenavir, and indinavir.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Abacavir sulfate Drug: Amprenavir Drug: Lamivudine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Safety Study |
| Official Title: | A Phase II, 48-Week, Uncontrolled, Open-Label Study Designed to Evaluate the Safety and Efficacy of Quadruple Antiretroviral Therapy (EPIVIR, Abacavir, Amprenavir, and Indinavir) in Subjects Acutely Infected With HIV-1 |
| Estimated Enrollment: | 30 |
Patients receive a four-drug regimen consisting of two nucleoside reverse transcriptase inhibitors (3TC and abacavir) and two protease inhibitors (amprenavir and indinavir) for a minimum of 48 weeks. At specified time points, patients undergo physical assessments and efficacy evaluations which include plasma HIV-1 RNA measurements and CD4 cell counts. Depending on the immunologic and virologic status of the patient, further testing may be done to determine whether quadruple drug therapy can attain undetectable viral levels.
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed with caution and/or careful monitoring:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
- Radiation therapy within 30 days of study entry.
Risk Behavior:
Excluded:
Alcohol or illicit drug use which, in the opinion of the investigator, may interfere with ability to comply with the dosing schedule and protocol evaluations.
Contacts and Locations| United States, New York | |
| Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ | |
| New York, New York, United States, 10021 | |
| United States, Rhode Island | |
| Miriam Hosp / Family Healthcare Ctr at SSTAR | |
| Providence, Rhode Island, United States, 02906 | |
More Information
| Study ID Numbers: | 264K, COLA 2012 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002233 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination HIV Protease Inhibitors CD4 Lymphocyte Count |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
|
Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Indinavir Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Bacterial Agents Amprenavir Anti-Retroviral Agents Therapeutic Uses Abacavir 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 Antibiotics, Antitubercular Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases |