Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080119
Status:
TERMINATED
Last Update Posted:
2019-02-05
First Post:
2004-03-23
Brief Title:
Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV
Sponsor:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Organization:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Study Overview
Official Title:
A Randomized Double Blind Placebo Controlled Trial to Determine the Efficacy of Isoniazid INH in Preventing Tuberculosis Disease and Latent Tuberculosis Infection Among Infants With Perinatal Exposure to HIV
Status:
TERMINATED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Data Safety Monitoring Board DSMB recommended stopping study due to futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tuberculosis TB is highly endemic in sub-Saharan Africa The increased burden of TB in settings with high prevalence of the Human Immunodeficiency Virus HIV is associated with high rates of transmission of Mycobacterium tuberculosis Mtb to both adults and children Children infected with TB have a higher risk of developing severe disease than adults with TB The purpose of this study was to determine if the antibiotic isoniazid INH prevented TB infection in infants born to HIV-infected mothers
Detailed Description:
Tuberculosis TB and the Human Immunodeficiency Virus 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 Isoniazid 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 evaluated the effectiveness of INH prophylaxis in preventing TB infection in infants born to HIV-infected mothers in southern Africa
Infants were 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 received daily trimethoprimsulfamethoxazole TMPSMX as Pneumocystis jiroveci pneumonia PCP prophylaxis until at least 1 year of age HIV-uninfected infants received TMPSMX until at least 6 months of age
The study was to follow participants for 192 weeks Study visits occurred at study entry and every 12 weeks until week 192 A physical exam and blood collection occurred at each study visit Infants were assessed for peripheral neuropathy every 12 weeks until week 96 and for TB at weeks 96 144 and 192 The study also assessed medication adherence
As of November 12 2008 follow-up was revised All participants were permanently discontinued from study follow-up by February 28 2009 and no later than May 31 2009 Only clinical evaluations were performed for all participants For HIV-infected participants the study drug was stopped at the next scheduled visit For HIV-uninfected subjects the study drug was discontinued immediately
Infants were 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 received daily trimethoprimsulfamethoxazole TMPSMX as Pneumocystis jiroveci pneumonia PCP prophylaxis until at least 1 year of age HIV-uninfected infants received TMPSMX until at least 6 months of age
The study was to follow participants for 192 weeks Study visits occurred at study entry and every 12 weeks until week 192 A physical exam and blood collection occurred at each study visit Infants were assessed for peripheral neuropathy every 12 weeks until week 96 and for TB at weeks 96 144 and 192 The study also assessed medication adherence
As of November 12 2008 follow-up was revised All participants were permanently discontinued from study follow-up by February 28 2009 and no later than May 31 2009 Only clinical evaluations were performed for all participants For HIV-infected participants the study drug was stopped at the next scheduled visit For HIV-uninfected subjects the study drug was discontinued immediately
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01AI068632 | NIH | None | httpsreporternihgovquickSearchU01AI068632 |