- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002230
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Univ Med School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Patients must have:
- HIV infection, as documented by a licensed ELISA that is confirmed either by Western blot, positive HIV culture, positive HIV antigen, positive plasma HIV RNA, or a second antibody test positive by a method other than ELISA.
- CD4 cell count of at least 100 cells/mm3 within 30 days of study entry.
- Over 500 HIV-1 RNA copies/ml as measured by the Roche Amplicor or Ultra Sensitive Assay within 30 days of study entry.
- Treatment-experienced patients must have documented HIV RNA values of less than or equal to 100,000 copies/ml within 30 days of study entry.
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:
- History of acute or chronic pancreatitis.
- History of generalized peripheral neuropathy.
- Inability to tolerate ddI at 200-400 mg/day or d4T at 60-80 mg/day. For purposes of this study, intolerance will be defined as the same recurrent toxicities requiring dose interruptions and dose reductions or permanent discontinuation of the drugs (other than Grade 3 or 4 anemia).
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Robert Murphy
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Antineoplastic Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Cytochrome P-450 CYP2B6 Inducers
- Antisickling Agents
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Stavudine
- Hydroxyurea
- Didanosine
- Efavirenz
Other Study ID Numbers
- 296A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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