Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002227
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1998

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002227 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
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

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.

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

Interventional
Phase 2
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Efavirenz
  • Drug: Lamivudine
  • Drug: Stavudine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
Not Provided

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.

Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002227
281C, DMP 266-043
Not Provided
Not Provided
Dupont Merck
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
November 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP