Track topics on Twitter Track topics that are important to you
HIV infected women in southern 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 southern Africa.
TB and HIV are major public health problems in southern 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 infants born to HIV infected mothers in southern Africa.
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. At sites in South Africa, HIV infected infants will receive daily sulfamethoxazole/trimethoprim (SMX/TMP) as Pneumocystis jiroveci pneumonia (PCP) prophylaxis until at least 1 year of age; HIV uninfected infants will receive SMX/TMP until at least 6 months of age. In Malawi, HIV exposed infants will be given SMX/TMP until they are confirmed HIV negative at 18 months of age; HIV infected infants will continue receiving prophylaxis.
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.
As of November 12, 2008, Follow-up has been revised. All participants will be permanently discontinued from study follow-up by February 28, 2009 and no later than May 31, 2009. Only clinical evaluations will be performed for all participants. For HIV-infected participants, the study drug will be stopped at the next scheduled visit. For HIV-uninfected subjects, the study drug is discontinued immediately.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
University of Cape Town, Red Cross Children's Hospital
Active, not recruiting
National Institute of Allergy and Infectious Diseases (NIAID)
Published on BioPortfolio: 2014-08-27T03:54:31-0400
The purpose of this study is to determine whether trimethoprim/sulfamethoxazole is effective in preventing serious infectious complications (those that require hospitalization or lead to d...
Background: In many communities, skin and soft tissue infections (SSTI) with MRSA have become more prevalent than infections with β-lactam susceptible bacteria. This has necessitated alt...
To determine the effects of fluconazole and either rifabutin or clarithromycin, alone and in combination, on the pharmacokinetics of first sulfamethoxazole-trimethoprim and then dapsone in...
A Randomized, Double-Blind, Placebo Controlled Study of l-Leucovorin in Combination With Trimethoprim / Sulfamethoxazole in the Therapy of Pneumocystis Carinii Pneumonia in Patients With the Acquired Immunodeficiency Syndrome
The primary objective of the study is to evaluate the effectiveness of l-leucovorin in preventing toxicity from high dose trimethoprim / sulfamethoxazole (TMP / SMX) used as a therapy for ...
To determine if the pharmacokinetics of high doses of zidovudine (AZT) (that is, how fast AZT reaches the blood, what concentration of AZT is attained in the blood, and how long AZT remain...
Stenotrophomonas maltophilia causes high mortality rates, especially in bloodstream infections (BSI) where there is a lack of comparative data with fluoroquinolones (FQs) and sulfamethoxazole/trimetho...
In antineutrophil cytoplasmic antibodies-associated vasculitis (AAV), the treatment of choice is either Rituximab or cyclophosphamide in combination with steroids. In less extended forms of AAV, howev...
Trimethoprim is one of the most widely used antibiotics in the world. However its efficacy is frequently limited by its poor water solubility and dose limiting toxicity. Prodrug strategies based on co...
While trimethoprim-sulfamethoxazole is considered first-line therapy for Pneumocystis pneumonia prevention in renal transplant recipients, reported adverse drug reactions may limit use and increase re...
Immunosuppressant medications (ISPs) increase the occurrence of Pneumocystis jirovecii pneumonia (PCP) in rheumatoid arthritis (RA) patients. The prophylactic administration of trimethoprim/sulfametho...
A pyrimidine inhibitor of dihydrofolate reductase, it is an antibacterial related to PYRIMETHAMINE. The interference with folic acid metabolism may cause a depression of hematopoiesis. It is potentiated by SULFONAMIDES and the TRIMETHOPRIM-SULFAMETHOXAZOLE COMBINATION is the form most often used. It is sometimes used alone as an antimalarial. TRIMETHOPRIM RESISTANCE has been reported.
A drug combination with broad-spectrum antibacterial activity against both gram-positive and gram-negative organisms. It is effective in the treatment of many infections, including PNEUMOCYSTIS PNEUMONIA in AIDS.
This drug combination has proved to be an effective therapeutic agent with broad-spectrum antibacterial activity against both gram-positive and gram-negative organisms. It is effective in the treatment of many infections, including PNEUMOCYSTIS PNEUMONIA in AIDS.
Nonsusceptibility of bacteria to the action of TRIMETHOPRIM.
Tuberculosis resistant to chemotherapy with two or more ANTITUBERCULAR AGENTS, including at least ISONIAZID and RIFAMPICIN. The problem of resistance is particularly troublesome in tuberculous OPPORTUNISTIC INFECTIONS associated with HIV INFECTIONS. It requires the use of second line drugs which are more toxic than the first line regimens. TB with isolates that have developed further resistance to at least three of the six classes of second line drugs is defined as EXTENSIVELY DRUG-RESISTANT TUBERCULOSIS.
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...
Tuberculosis (TB) is an infectious disease caused by bacteria belonging to the Mycobacterium tuberculosis complex. Over nine million new cases of TB, and nearly two million deaths from TB, are estimated to occur around the world every year, and new inf...