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Sponsored by: |
Dupont Merck |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002225 |
The purpose of this study is to see if it is safe and effective to give efavirenz plus stavudine plus didanosine to HIV-infected patients who have never received anti-HIV treatment.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Efavirenz Drug: Stavudine Drug: Didanosine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | A Phase II, Open-Label, Multicenter Study to Characterize the Effectiveness and Safety of Efavirenz in Combination With Stavudine and Didanosine in Antiretroviral Therapy-Naive HIV-Infected Patients |
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Astemizole, cisapride, clarithromycin, ketoconazole, itraconazole, midazolam, rifabutin, rifampin, terfenadine, thalidomide, triazolam, vincristine, zalcitabine.
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Risk Behavior:
Excluded:
- Current alcohol or illicit drug use which would interfere with compliance with dosing schedule and protocol evaluations.
United States, District of Columbia | |
The Whitman Walker Clinic | |
Washington, District of Columbia, United States, 20009 | |
United States, Illinois | |
AIDS Research Alliance - Chicago | |
Chicago, Illinois, United States, 60657 | |
United States, New York | |
North Shore AIDS Hosp / Division of Infectious Disease | |
Manhassett, New York, United States, 11030 | |
Univ of Rochester Med Ctr | |
Rochester, New York, United States, 14642 | |
United States, North Carolina | |
Carolinas Research Associates | |
Charlotte, North Carolina, United States, 28207 |
Study ID Numbers: | 281D, DMP 266-044 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002225 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Didanosine Drug Therapy, Combination Stavudine Reverse Transcriptase Inhibitors efavirenz |
Antimetabolites Efavirenz Sexually Transmitted Diseases, Viral Anti-HIV Agents Stavudine Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes |
Reverse Transcriptase Inhibitors Virus Diseases Didanosine Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Molecular Mechanisms of Pharmacological Action 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 |