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Sponsors and Collaborators: |
Gilead Sciences Bristol-Myers Squibb Glaxo Wellcome Dupont Pharmaceuticals |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00002234 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Efavirenz Drug: Adefovir dipivoxil Drug: Lamivudine Drug: Didanosine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
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 |
Estimated Enrollment: | 25 |
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.
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 |
Study ID Numbers: | 232J, ICC 604 |
Study First Received: | November 2, 1999 |
ClinicalTrials.gov Identifier: | NCT00002234 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Drug Therapy, Combination Reverse Transcriptase Inhibitors Anti-HIV Agents |
Antimetabolites Efavirenz Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Lamivudine Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors |
Virus Diseases Didanosine Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Adefovir dipivoxil Retroviridae Infections Adefovir |
Antimetabolites Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors Efavirenz RNA Virus Infections |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections Adefovir dipivoxil Adefovir |