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Vitamin A Therapy for Tuberculosis



Vitamin A Therapy for Tuberculosis

For Condition: Pulmonary Tuberculosis,HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The study will determine whether a daily vitamin and mineral supplement (a multivitamin including Vitamin A) will improve health when added to standard chemotherapy for tuberculosis. This study will compare the effectiveness of the multivitamin in HIV infected and HIV uninfected patients.
Details: By the year 2000, 13.8 % of individuals with HIV will be co-infected with tuberculosis (TB). Despite effective TB chemotherapy, mortality rates remain extremely high, and no simple, inexpensive intervention is available. Prior to the discovery of antibiotic treatment, cod-liver oil, a potent source of Vitamin A, was the standard treatment for TB. Vitamin A is essential for normal immune function, and Vitamin A supplementation is used in many countries to reduce mortality in children. Vitamin A deficiency in HIV infected people has been associated with increased mortality in the United States, Haiti, Malawi, and Uganda. This study will determine whether daily Vitamin A supplementation, given concurrently with TB chemotherapy, will reduce mortality in adults with HIV and TB. All study participants will receive standard TB chemotherapy (isoniazid, rifampicin, streptomycin, pyrazinamide) for the first 2 months, followed by isoniazid and ethambutol for the following 6 months. Participants will be randomized to receive either a daily vitamin and mineral supplement or placebo. Participants will be followed for 24 months after study enrollment.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Sputum-confirmed pulmonary tuberculosis - Resident of Zomba or Blantyre Districts, Malawi - Willing to take tuberculosis chemotherapy as recommended by the National Tuberculosis Control Programme Exclusion Criteria: - Prior treatment for tuberculosis
Total Enrollment: 1140

Location and Contact Information:

Overall Study Official:
RichardSemba,  Principal Investigator,  Johns Hopkins University

Zomba Central Hospital *Recruiting*
Zomba,  , 
Malawi
Recruiting Richard  Semba 410 955-3572


Additional Information:
Study ID Numbers:
  5R01AI41956-05; 
Study Start Date: September 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057434

Other Pulmonary Tuberculosis Studies:
1. A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo

2. The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment

3. Safety and Effectiveness of the Oral HIV Entry Inhibitor SCH 417690 in HIV Infected Patients

4. Open label safety study (OLSS) of tipranavir/ritonavir in HIV patients with limited treatment options

5. A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months

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Vitamin A Therapy for Tuberculosis

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