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Sponsored by: |
Northwestern University |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002230 |
To determine the virologic benefits associated with the addition of hydroxyurea (HU) to combination drug therapy with didanosine (ddI), stavudine (d4T), and efavirenz (DMP) in HIV-infected patients. To assess the safety and tolerance of this regimen, with or without HU.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Hydroxyurea Drug: Efavirenz Drug: Stavudine Drug: Didanosine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | A Randomized, Placebo-Controlled Study of the Safety and Efficacy of Efavirenz, Didanosine, and Stavudine in Combination With or Without Hydroxyurea in Antiretroviral Naive or Experienced HIV-Infected Patients |
Estimated Enrollment: | 100 |
HU or placebo is added 30-60 days after the initiation of DMP, ddI, and d4T combination therapy. Patients are stratified according to antiretroviral experience (naive or experienced). Patients are followed for 48 weeks to determine safety, efficacy, and effect of treatment on viral, immunologic,and biochemical parameters.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Prior Treatment:
Excluded:
Acute therapy for an infection or other medical illness. Acute therapy must have been completed 14 days prior to the time of study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Malignancy requiring systemic therapy.
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Antiretroviral therapy. If antiretroviral-experienced, no prior NNRTI's or HU and no more than 12 weeks experience with ddI and/or d4T. Protease inhibitor experience is allowed. Experienced patients must be on a stable antiretroviral therapy 30 days prior to study screening and continue this regimen until study entry.
Risk Behavior:
Excluded:
Current ethanol abuse by personal history or a report from a primary physician.
Study ID Numbers: | 296A |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002230 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Didanosine Drug Therapy, Combination Stavudine Hydroxyurea Anti-HIV Agents |
Antimetabolites Anti-Infective Agents Efavirenz Sexually Transmitted Diseases, Viral Stavudine Anti-HIV Agents Hydroxyurea 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 Antineoplastic Agents Hydroxyurea Hematologic Agents Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
Efavirenz RNA Virus Infections Antisickling Agents 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 |