A Phase II, Open-Label, Multicenter Study to Characterize the Effectiveness and Safety of Efavirenz in Combination With Stavudine and Lamivudine in Antiretroviral Therapy-Naive HIV-Infected Patients

A Study of Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Sponsors

Lead sponsor: Dupont Merck

Source NIH AIDS Clinical Trials Information Service
Brief Summary

The purpose of this study is to see if it is safe and effective to give efavirenz plus stavudine plus lamivudine to patients who have never taken anti-HIV drugs.

Detailed Description

Patients will be given combination treatment with efavirenz, stavudine, and lamivudine.

Overall Status Completed
Phase Phase 2
Study Type Interventional
Enrollment 60
Condition
Intervention

Intervention type: Drug

Intervention name: Efavirenz

Intervention type: Drug

Intervention name: Lamivudine

Intervention type: Drug

Intervention name: Stavudine

Eligibility

Criteria:

Inclusion Criteria

Patients must have:

- Documented diagnosis of HIV infection with plasma HIV-RNA greater than or equal to 10,000 copies/ml.

- 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.

- Proven or suspected acute hepatitis due to any cause.

- Recurrent episodes of moderate to severe diarrhea, or vomiting lasting for more than 4 days within 3 months prior to dosing.

- Hypersensitivity to any component of the formulation of efavirenz, stavudine, or lamivudine.

- 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 found during the screening of medical history or physical examination.

- Any malignancy that requires systemic therapy.

- Any active AIDS-defining opportunistic infection or disease.

Concurrent Medication:

Excluded:

Astemizole, cisapride, clarithromycin, ketoconazole, itraconazole, midazolam, rifabutin, rifampin, terfenadine, thalidomide, triazolam, vincristine, zalcitabine or any medications contraindicated for concomitant use with stavudine or lamivudine as described in the current information package insert.

Patients with the following prior conditions are excluded:

- History of acute or chronic pancreatitis.

- A life expectancy of less than 12 months.

- Difficulty swallowing capsules/tablets.

- Inability to communicate effectively with study personnel.

Prior Medication:

Excluded:

- Any other experimental drug within 30 days of introducing study treatment.

- Vaccination within 3 weeks of screening visit.

- Any prior antiretroviral therapy.

- Interferon started within 30 days of initiating study treatment.

Risk Behavior:

Excluded:

Current alcohol or illicit drug use which interferes with patient's ability to follow study regimen.

Gender: All

Minimum age: 13 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility
Richard Elion | Washington, District of Columbia, 20009, United States
The Whitman Walker Clinic | Washington, District of Columbia, 20009, United States
Community Research Initiative of New England | Brookline, Massachusetts, 02445, United States
Remington Davis Inc | Columbus, Ohio, 43215, United States
The Milton S Hersey Med Ctr / Div of Hematology | Hershey, Pennsylvania, 170330850, United States
Coastal Carolina Research Ctr | Mount Pleasant, South Carolina, 29464, United States
Montrose Clinic | Houston, Texas, 77006, United States
Hampton Roads Med Specialists | Hampton, Virginia, 23666, United States
Location Countries

United States

Verification Date

November 1998

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Primary purpose: Treatment

Source: ClinicalTrials.gov