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A Study of Efavirenz in Combination With Stavudine and Didanosine

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Efavirenz
Stavudine
Didanosine
Sponsored by
Dupont Merck
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drug Therapy, Combination, Stavudine, Reverse Transcriptase Inhibitors, efavirenz

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Whitman Walker Clinic
  • AIDS Research Alliance - Chicago
  • North Shore AIDS Hosp / Division of Infectious Disease
  • Univ of Rochester Med Ctr
  • Carolinas Research Associates

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Dupont Merck
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1. Study Identification

Unique Protocol Identification Number
NCT00002225
Brief Title
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

2. Study Status

Record Verification Date
November 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Dupont Merck

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Didanosine, Drug Therapy, Combination, Stavudine, Reverse Transcriptase Inhibitors, efavirenz

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Efavirenz
Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Type
Drug
Intervention Name(s)
Didanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
The Whitman Walker Clinic
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
AIDS Research Alliance - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
North Shore AIDS Hosp / Division of Infectious Disease
City
Manhassett
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Carolinas Research Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States

12. IPD Sharing Statement

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A Study of Efavirenz in Combination With Stavudine and Didanosine

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