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A Study of Efavirenz in Combination With Stavudine and Didanosine

D

Dupont Merck

Status and phase

Completed
Phase 2

Conditions

HIV Infections

Treatments

Drug: Stavudine
Drug: Efavirenz
Drug: Didanosine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002225
DMP 266-044
281D

Details and patient eligibility

About

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.

Full description

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

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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