A Study of Efavirenz in Combination With Stavudine and Didanosine

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002225
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1998

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002225 on ClinicalTrials.gov Archive Site
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A Study of Efavirenz in Combination With Stavudine and Didanosine
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

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.

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

Interventional
Phase 2
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Efavirenz
  • Drug: Stavudine
  • Drug: Didanosine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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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.

Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002225
281D, DMP 266-044
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Dupont Merck
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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