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| Descriptive Information Fields | |
| Brief Title † | Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment |
| 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 |
| Brief Summary | 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). |
| Detailed Description | 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. |
| Study Phase | Phase II |
| Study Type † | Interventional |
| Study Design † | Treatment, Safety Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | HIV Infections |
| Intervention † | Drug: Abacavir sulfate Drug: Amprenavir Drug: Efavirenz Drug: Adefovir dipivoxil |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 25 |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | Inclusion Criteria You may be eligible for this study if you:
Exclusion Criteria You will not be eligible for this study if you:
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| Gender | Both |
| Ages | 13 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00002419 |
| Organization ID | 299A |
| Secondary IDs †† | ICC 605 |
| Study Sponsor † | Gilead Sciences |
| Collaborators †† | Glaxo Wellcome Dupont Pharmaceuticals |
| Investigators † | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | November 1999 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | June 23, 2005 |