Clinical trial NCT00002227: A Study of Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Stavudine
Lamivudine
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 lamivudine to patients who have never taken anti-HIV drugs.

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

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Richard Elion
state: District of Columbia
city: Washington
country: United States
facility: The Whitman Walker Clinic
state: District of Columbia
city: Brookline
country: United States
facility: Community Research Initiative of New England
state: Massachusetts
city: Columbus
country: United States
facility: Remington Davis Inc
state: Ohio
city: Hershey
country: United States
facility: The Milton S Hersey Med Ctr / Div of Hematology
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Ctr
state: South Carolina
city: Houston
country: United States
facility: Montrose Clinic
state: Texas
city: Hampton
country: United States
facility: Hampton Roads Med Specialists
state: Virginia
Study officials:
References: