A Study of Efavirenz in Combination With Stavudine and Didanosine

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 Didanosine in Antiretroviral Therapy-Naive HIV-Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002225
• Other study ID #: 281D
• Secondary ID: DMP 266-044
• 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 didanosine to HIV-infected patients who have never received anti-HIV treatment.

Description:

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

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 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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Efavirenz

• Stavudine

• Didanosine

Locations

Country	Name	City	State
United States	Carolinas Research Associates	Charlotte	North Carolina
United States	AIDS Research Alliance - Chicago	Chicago	Illinois
United States	North Shore AIDS Hosp / Division of Infectious Disease	Manhassett	New York
United States	Univ of Rochester Med Ctr	Rochester	New York
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,