A Study of Efavirenz in Combination With Stavudine and Didanosine
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Efavirenz (Drug); Stavudine (Drug); Didanosine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Dupont Merck
Summary
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.
Clinical Details
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
Study design: Treatment, Safety Study
Detailed description:
Patients will be given combination treatment with efavirenz, stavudine, and didanosine.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Patients must have:
- Documented HIV infection with plasma HIV-RNA greater than or equal to 10,000
copies/ml.
- A life expectancy of at least 12 months.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Current bilateral peripheral neuropathy greater than or equal to Grade 2.
- Any clinically significant laboratory findings obtained during the screening
evaluation (see laboratory values).
- Any clinically significant disease (other than HIV infection) or clinically
significant findings during screening of medical history or physical examination.
- Any malignancy that requires systemic therapy.
- Proven or suspected acute hepatitis due to any cause.
- Recurrent episodes of moderate to severe diarrhea, or vomiting lasting more than 4
days within 3 months prior to dosing.
- Active AIDS-defining opportunistic infection or disease.
Concurrent Medication:
Excluded:
Astemizole, cisapride, clarithromycin, ketoconazole, itraconazole, midazolam, rifabutin,
rifampin, terfenadine, thalidomide, triazolam, vincristine, zalcitabine.
Patients with the following prior conditions are excluded:
- History of acute or chronic pancreatitis.
- Life expectancy less than 12 months.
- Difficulty in swallowing capsules/tablets.
- Hypersensitivity to any component of the formulation of efavirenz, stavudine, or
didanosine.
Prior Medication:
Excluded:
- Any other experimental drug within 30 days of introducing study treatment.
- Vaccination within 3 weeks of screening visit.
- Interferon started within 30 days of initiating study treatment.
- Prior antiretroviral therapy.
Risk Behavior:
Excluded:
- Current alcohol or illicit drug use which would interfere with compliance with dosing
schedule and protocol evaluations.
Locations and Contacts
The Whitman Walker Clinic, Washington, District of Columbia 20009, United States
AIDS Research Alliance - Chicago, Chicago, Illinois 60657, United States
North Shore AIDS Hosp / Division of Infectious Disease, Manhassett, New York 11030, United States
Univ of Rochester Med Ctr, Rochester, New York 14642, United States
Carolinas Research Associates, Charlotte, North Carolina 28207, United States
Additional Information
Last updated: June 23, 2005
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