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| Descriptive Information Fields | |
| Brief Title † | Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients |
| Official Title † | A Phase II, 48 Week, Open-Label Study Designed to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of a Simplified Dosing Regimen of Preveon (Adefovir Dipivoxil; bis-POM PMEA), Videx (Didanosine; ddI), Sustiva (Efavirenz; DMP-266), and Epivir (Lamivudine; 3TC) Administered Once Daily for the Treatment of HIV-1 Infection |
| Brief Summary | The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily. |
| Detailed Description | Patients receive a treatment regimen of adefovir dipivoxil, didanosine, efavirenz, and lamivudine for 48 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA and lymphocyte subsets and for the development of adverse experiences and laboratory toxicities. At Weeks 8, 12, 24, and 48, patients are assessed for adherence to study treatment with a questionnaire. Patients who experience virologic failure are discontinued from the study. Patients who experience treatment intolerance may have their antiretroviral treatment regimens changed. After Week 48, patients with documented virologic response are eligible to continue receiving study treatment. |
| Study Phase | Phase II |
| Study Type † | Interventional |
| Study Design † | Treatment, Safety Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | HIV Infections |
| Intervention † | Drug: Efavirenz Drug: Adefovir dipivoxil Drug: Lamivudine Drug: Didanosine |
| 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 † | NCT00002234 |
| Organization ID | 232J |
| Secondary IDs †† | ICC 604 |
| Study Sponsor † | Gilead Sciences |
| Collaborators †† | Bristol-Myers Squibb Glaxo Wellcome Dupont Pharmaceuticals |
| Investigators † | |
| Information Provided By | Bristol-Myers Squibb |
| Verification Date | November 2004 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | |