Clinical trial NCT00002225: A Study of Efavirenz in Combination With Stavudine and Didanosine
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Didanosine
Drug Therapy, Combination
Stavudine
Reverse Transcriptase Inhibitors
efavirenz
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

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

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: The Whitman Walker Clinic
state: District of Columbia
city: Chicago
country: United States
facility: AIDS Research Alliance - Chicago
state: Illinois
city: Manhassett
country: United States
facility: North Shore AIDS Hosp / Division of Infectious Disease
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Med Ctr
state: New York
city: Charlotte
country: United States
facility: Carolinas Research Associates
state: North Carolina
Study officials:
References: