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Sponsors and Collaborators: |
Gilead Sciences Glaxo Wellcome Dupont Pharmaceuticals |
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002419 |
The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil plus abacavir (ABC) plus efavirenz (EFV) plus amprenavir (APV) to HIV-infected patients who have failed to respond to previous treatment with protease inhibitors (PIs).
Condition | Intervention | Phase |
HIV Infections |
Drug: Abacavir sulfate Drug: Amprenavir Drug: Efavirenz Drug: Adefovir dipivoxil |
Phase II |
MedlinePlus related topics: | AIDS |
ChemIDplus related topics: | Abacavir Abacavir sulfate Efavirenz Adefovir dipivoxil Adefovir VX 478 |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | A Phase II, 24-Week, Open-Label Study Designed to Evaluate the Safety, Tolerability, and Efficacy of Novel Quadruple-Combination Therapy With Preveon (Adefovir Dipivoxil; Bis-POM PMEA), Abacavir (1592U89), Sustiva (Efavirenz; DMP-266), and Amprenavir (141W94) for the Treatment of HIV-1 Infection in Patients Who Have Failed Previous Protease Inhibitor Treatment |
Estimated Enrollment: | 25 |
Patients receive a treatment regimen of adefovir dipivoxil, abacavir, efavirenz, and amprenavir for 24 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. Patients who experience virologic failure are discontinued from the study. After Week 24, patients with documented virologic response are eligible to continue receiving the study treatment and to attend scheduled follow-up visits.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
United States, California | |||||
Pacific Oaks Med Group | |||||
Beverly Hills, California, United States, 90211 | |||||
United States, Colorado | |||||
Univ of Colorado / Health Science Ctr | |||||
Denver, Colorado, United States, 80262 | |||||
United States, Georgia | |||||
AIDS Research Consortium of Atlanta | |||||
Atlanta, Georgia, United States, 30308 | |||||
United States, Rhode Island | |||||
Brown Univ School of Medicine | |||||
Providence, Rhode Island, United States, 02908 | |||||
United States, Virginia | |||||
Hampton Roads Med Specialists | |||||
Hampton, Virginia, United States, 23666 |
Gilead Sciences |
Glaxo Wellcome |
Dupont Pharmaceuticals |
Study ID Numbers: | 299A, ICC 605 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002419 |
Health Authority: | United States: Food and Drug Administration |
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