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Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers with HIV Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers with HIV conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers with HIV Clinical research trials and Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers with HIV healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers with HIV. Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers with HIV Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers with HIV clinical trial. Human subjects often obtain the finest healthcare possible for their Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers with HIV condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers with HIV  Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers with HIV
Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers with HIV
For Condition: HIV Infections,Pneumocystis carinii Pneumonia,Tuberculosis
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Secure the Future Foundation
Synopsis: HIV infected women in South Africa have a high risk of tuberculosis (TB) infection. Children born to HIV infected mothers may be more likely to be exposed to and become infected with TB, and children infected with TB have a higher risk of developing severe disease than adults with TB. The purpose of this study is to determine if the antibiotic isoniazid (INH) will prevent TB infection in infants born to HIV infected mothers in South Africa.
Details: TB and HIV are major public health problems in South Africa, and the incidence of TB in South Africa is among the highest in the world. TB is caused by the highly contagious bacterium Mycobacterium tuberculosis. The use of INH prophylaxis in adults has been associated with reduced risk of TB disease in high-risk populations. Delay in initiating INH prophylaxis in children has resulted in more cases of childhood TB infection. This study will evaluate the effectiveness of INH prophylaxis in preventing TB infection in South African infants born to HIV infected mothers. Infants will be randomly assigned to receive either INH or placebo by mouth daily, beginning between the 91st and 120th day of life, and at least 90 days after Bacille Calmette-Guerin (BCG) vaccination. HIV infected infants will receive daily sulfamethoxazole-trimethoprim (SMX/TMP) as Pneumocystic carinii pneumonia (PCP) prophylaxis until at least 1 year of age; HIV uninfected infants will receive SMX/TMP until at least 6 months of age. This study will last 192 weeks. Study visits will occur at study entry and every 12 weeks until Week 192. A physical exam and blood collection will occur at each study visit. Infants will be assessed for peripheral neuropathy every 12 weeks until Week 96 and for TB at Weeks 96, 144, and 192. The study will also assess medication adherence.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 91 Days/120 Days
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Mother is HIV infected - Received Bacille Calmette-Guerin (BCG) vaccine during the first week of life - Able to complete all study requirements - Normal truncated Denver Developmental Test for peripheral neuropathy at study entry - Normal deep tendon reflexes and muscle bulk, tone, and strength at study entry - Plan to live in the study area for at least 4 years Exclusion Criteria: - Previous diagnosis of TB infection - Previous receipt of INH - Contact with a known acid fast bacilli (AFB) sputum smear or culture-positive case of TB before study entry - Current acute or recurrent (3 or more prior episodes) lower respiratory tract disease - Chronic persistent diarrhea - Significant drop in weight or failure to gain weight appropriately during a 2 to 3 month period - Contraindications for use of INH or SMX/TMP - Use of certain medications - Known or suspected immune system diseases other than HIV - Current or previous diagnosis of or treatment for cancer - Current immunosuppressive therapy greater than 1 mg/kg/day of prednisone or equivalent - Anticipated long-term oral or intravenous corticosteroid therapy (greater than 3 weeks). Those receiving nonsteroidal anti-inflammatory agents and inhaled corticosteroids are not excluded. - Grade 2 or greater AST/SGOT, ALT/SGPT, ANC, hemoglobin, platelet count, rash, neuropathy, or myopathy at screening - Any Grade 4 clinical or laboratory toxicity within 14 days prior to study entry - Other acute or chronic conditions that, in the opinion of the investigator, may interefere with the study
Total Enrollment: 1300
Location and Contact Information:
Overall Study Official:
GeorgeMcSherry, Study Chair, UMD - New Jersey Medical School
Chris Hani Baragwanath Hospital
Johannesburg, ,
South Africa
University of Stellenbosch, Tygerberg Hospital
Cape Town, ,
South Africa
University of Cape Town, Red Cross Children's Hospital
Cape Town, ,
South Africa
Additional Information:
Study ID Numbers: PACTG P1041;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080119
Other Hiv Infections Studies:
1. An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts
2. A Study of Zidovudine and T Lymphocyte Transfer in the Treatment of HIV Type III in Patients with AIDS
3. Treatment of Psoriasis Using Acitretin in HIV-Positive Patients
4. The Effectiveness of GM-CSF in HIV-Positive Patients Who Are Also Receiving Anti-HIV Therapy
5. A Study to Examine the Effects of Stopping Preventive Therapy for Disseminated Mycobacterium Avium Complex (DMAC) in HIV-Positive Patients
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Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers with HIV
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