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
Completed · Phase 3
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002230
- Run by
- Northwestern University
- People needed
- 100
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Northwestern Univ Med School — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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