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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002227
• Other study ID #: 281C
• Secondary ID: DMP 266-043
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 1998
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Efavirenz

• Lamivudine

• Stavudine

Locations

Country	Name	City	State
United States	Community Research Initiative of New England	Brookline	Massachusetts
United States	Remington Davis Inc	Columbus	Ohio
United States	Hampton Roads Med Specialists	Hampton	Virginia
United States	The Milton S Hersey Med Ctr / Div of Hematology	Hershey	Pennsylvania
United States	Montrose Clinic	Houston	Texas
United States	Coastal Carolina Research Ctr	Mount Pleasant	South Carolina
United States	Richard Elion	Washington	District of Columbia
United States	The Whitman Walker Clinic	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Dupont Merck

Country where clinical trial is conducted

United States,