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Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients with HIV-Related Tuberculosis Treated with a Rifabutin-Based Regimen



Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients with HIV-Related Tuberculosis Treated with a Rifabutin-Based Regimen

For Condition: HIV Infections,Tuberculosis
Status: No longer recruiting
Sponsor(s): Centers for Disease Control and Prevention , Department of Veterans Affairs
Synopsis: Primary Objective: To define the impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on peak levels and area under the curve for rifabutin and the rifabutin metabolite, 25-O-desacetyl rifabutin when rifabutin is given at 300 mg bi-weekly as part of tuberculosis chemotherapy. Secondary Objectives: To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin. To evaluate the correlation between pharmacokinetic parameters of rifabutin and 25-O-desacetyl rifabutin and the occurrence of toxicity attributed to rifabutin in patients with HIV-related tuberculosis. To define detailed pharmacokinetics of isoniazid given at 15mg/kg or 900 mg in patients with HIV-related tuberculosis. To attempt to derive optimal sampling times for nelfinavir and rifabutin pharmacokinetic studies.
Details:
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: - Patients with HIV-related tuberculosis
Total Enrollment: 

Location and Contact Information:

Thomas Street Clinic
Houston,  Texas,  77009
United States
 

Seattle King County Health Department
Seattle,  Washington,  98104
United States
 

Nashville VA Medical Center
Nashville,  Tennessee,  37212-2637
United States
 

Montreal Chest Institute McGill University
Montreal,  Quebec,  H2X 2P4Pq Canada
Canada
 

New Jersey Medical School
Newark,  New Jersey,  07107-3001
United States
 

New York University School of Medicine
New York City,  New York,  10016
United States
 

Denver Department of Public Health and Hospitals
Denver,  Colorado,  80204
United States
 

University of North Texas Health Science Center
Ft. Worth,  Texas,  76107-2699
United States
 

University of California, San Francisco
San Francisco,  California,  94110
United States
 

Columbia University/Presbyterian Medical Center
New York City,  New York,  10032
United States
 

Washington, D.C. VAMC
Washington D.C.,  District of Columbia,  20422
United States
 

Central Arkansas Veterans Health System
Little Rock,  Arkansas,  72205
United States
 

Johns Hopkins University School of Medicine
Baltimore,  Maryland,  21287-0003
United States
 

Boston Medical Center
Boston,  Massachusetts,  02118
United States
 

Hines VA Medical Center
Hines,  Illinois,  60141
United States
 

University of Manitoba
Winnipeg,  Manitoba,  CANADA R3A 1R8
Canada
 

Audi L. Murphy VA Hospital
San Antonio,  Texas,  78284
United States
 

Duke University Medical Center
Durham,  North Carolina,  34222
United States
 

Harlem Hospital Center
New York City,  New York,  10037
United States
 

University of British Columbia
Vancouver,  British Columbia,  Canada V5Z 4R4
Canada
 

Chicago VA Medical Center (Lakeside)
Chicago,  Illinois,  60611
United States
 

Carolinas Medical Center
Charlotte,  North Carolina,  28203
United States
 

LA County/USC Medical Center
Los Angeles,  California,  90033
United States
 


Additional Information:
Study ID Numbers:
  2587;  23B
Study Start Date: 
Record last reviewed: February 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023400

Other Hiv Infections Studies:
1. Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection

2. Effectiveness of Anti-HIV Therapy (HAART) in HIV-Infected Patients with Tuberculosis

3. Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients with HIV-Related Tuberculosis Treated with a Rifabutin-Based Regimen

4. Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen

5. Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis

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Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients with HIV-Related Tuberculosis Treated with a Rifabutin-Based Regimen

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