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Sponsored by: |
Glaxo Wellcome |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002213 |
The purpose of this study is to see if it is safe and effective to give 1592U89 plus 141W94 plus DMP 266 to patients with HIV who have developed resistance to indinavir, ritonavir, saquinavir, or nelfinavir after at least 20 weeks of protease inhibitor treatment. This study also examines how long this combination therapy is effective before patients develop resistance to it.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Abacavir sulfate Drug: Amprenavir Drug: Efavirenz |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | A Phase II Study Evaluating the Safety and Antiviral Activity of Combination Therapy With 1592U89, 141W94 and DMP 266 in HIV-1 Infected Subjects With Detectable HIV-1 Plasma RNA Despite Treatment With a Protease Inhibitor Containing Regimen |
Estimated Enrollment: | 80 |
This is a multicenter, open-label study. A total of 80 patients are treated on this study and include:
At least 30 patients with a viral burden of 500 - 40,000 copies/ml. At least 30 patients with a viral burden greater than 40,000 copies/ml. At least 20 patients with less than 1 year total prior treatment with nucleoside reverse transcriptase inhibitors (NRTIs).
All patients receive self-administered, combination antiretroviral therapy for 48 weeks, as follows:
1592U89 plus 141W94 plus DMP 266.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Anticipated need for radiation therapy (with the exception of local treatment for Kaposi's sarcoma).
Patients with the following symptoms and conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Radiation therapy.
Required:
United States, California | |
Kraus Med Partners | |
Los Angeles, California, United States, 90036 | |
East Bay AIDS Ctr | |
Berkeley, California, United States, 94705 | |
United States, Illinois | |
Northwestern Univ Med School AIDS Treatment Unit | |
Chicago, Illinois, United States, 60611 | |
United States, Maryland | |
NIAID / NIH | |
Bethesda, Maryland, United States, 20892 | |
United States, Massachusetts | |
Beth Israel Deaconess Med Ctr | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Saint Vincents Hosp / AIDS Ctr / 4th Floor | |
New York, New York, United States, 10011 | |
United States, North Carolina | |
Univ of North Carolina Chapel Hill | |
Chapel Hill, North Carolina, United States, 27499 | |
United States, Ohio | |
Univ Int Med Assoc Inc / Holmes Hosp / U of Cincinnati | |
Cincinnati, Ohio, United States, 45267 | |
United States, Rhode Island | |
The Miriam Hosp | |
Providence, Rhode Island, United States, 02906 |
Study ID Numbers: | 264F, CNAA2007 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002213 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV-1 Drug Therapy, Combination Antiviral Agents HIV Protease Inhibitors RNA, Viral |
VX 478 Anti-HIV Agents abacavir efavirenz |
Anti-Infective Agents Efavirenz Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Protease Inhibitors |
Virus Diseases Anti-Bacterial Agents Amprenavir Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Antitubercular Agents Abacavir Retroviridae Infections |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Bacterial Agents Amprenavir Anti-Retroviral Agents Therapeutic Uses Abacavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors Efavirenz RNA Virus Infections |
HIV Protease Inhibitors 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 Lentivirus Infections Antitubercular Agents |