Evaluating the Safety of Immediate Versus Deferred Isoniazid Preventive Therapy Among HIV-Infected Pregnant Women
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ClinicalTrials.gov Identifier: NCT01494038 |
Recruitment Status
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Completed
First Posted
: December 16, 2011
Last Update Posted
: September 20, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | December 14, 2011 | |||
First Posted Date ICMJE | December 16, 2011 | |||
Last Update Posted Date | September 20, 2017 | |||
Actual Study Start Date ICMJE | April 2014 | |||
Actual Primary Completion Date | September 6, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Grade 3 or higher adverse events (AEs) [ Time Frame: Measured through Week 48 postpartum ] Grade 3 or higher AEs possibly, probably, or definitely associated with INH/placebo for INH or permanent discontinuation of INH/placebo for INH due to an adverse reaction in women after randomization
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Original Primary Outcome Measures ICMJE |
Grade 3 or higher adverse events (AEs) [ Time Frame: Measured through Week 48 postpartum ] Grade 3 or higher AEs possibly, probably or definitely associated with INH/Placebo for INH or permanent discontinuation of INH/Placebo for INH due to an adverse reaction in women after randomization
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Change History | Complete list of historical versions of study NCT01494038 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Evaluating the Safety of Immediate Versus Deferred Isoniazid Preventive Therapy Among HIV-Infected Pregnant Women | |||
Official Title ICMJE | A Phase IV Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety of Immediate (Antepartum-Initiated) Versus Deferred (Postpartum-Initiated) Isoniazid Preventive Therapy Among HIV-Infected Women in High Tuberculosis (TB) Incidence Settings | |||
Brief Summary | Tuberculosis (TB) is a leading cause of death among HIV-infected persons in low-income settings and can be a serious complication for HIV-infected pregnant women and their infants. Isoniazid (INH) preventive therapy (IPT) is effective for HIV-infected adults, but the safety of IPT in pregnant women is unknown. This study will evaluate the safety of IPT among HIV-infected pregnant women. | |||
Detailed Description | TB disease is the most common HIV-related opportunistic infection and is a leading cause of death among HIV-infected persons in low-income settings. When TB occurs during or soon after pregnancy, it can cause complications for the mother as well as infant TB or death. Infant TB is very difficult to diagnose, and up to half of infant TB cases are caused by maternal TB. It has been shown that treatment for active TB is safe and effective during pregnancy and that IPT is safe and effective in preventing TB infection in HIV-infected adults. However, the safety of IPT in HIV-infected pregnant women is not known, especially in regard to its combination with highly active retroviral therapy (HAART). This study will evaluate the safety of immediate (antepartum, or before delivery) versus deferred (postpartum, or after delivery) IPT among HIV-infected pregnant women in high TB incidence settings. HIV-infected pregnant women will be randomly assigned to one of two arms. Arm A (immediate/antepartum INH) will receive oral INH once daily from study entry through Week 28 antepartum. At Week 28 antepartum, Arm A will receive oral placebo once daily until Week 40 postpartum. Arm B (deferred/postpartum INH group) will receive oral placebo once daily from study entry to Week 12 postpartum. At Week 12 postpartum, Arm B will receive oral INH once daily through Week 40 postpartum. Women in both arms will receive oral prenatal multivitamins and pyridoxine (vitamin B6) once daily from study entry through Week 40 postpartum. Study visits for women will occur at screening, entry, every 4 weeks until labor and delivery, at labor and delivery, and every 4 weeks after delivery until 48 weeks postpartum. Visits will consist of giving a medical history and undergoing a physical exam and blood collection; all visits through the delivery visit will also include an obstetrical exam. Presence of HIV infection will be documented at screening and a tuberculin skin test (TST) will be administered at the delivery visit and at the Week 44 postpartum visit. Some postpartum visits will include a urine pregnancy test. Study visits for infants will occur at birth and at several time points through Week 48. These visits will include a medical history, physical exam, and blood collection. Plasma collected from women and infants during this study will be stored for future studies. Some women and infants may have hair samples collected during the study, but this is optional. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Care Provider) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
956 | |||
Original Estimated Enrollment ICMJE |
950 | |||
Actual Study Completion Date | September 6, 2017 | |||
Actual Primary Completion Date | September 6, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 13 Years and older (Child, Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Botswana, Haiti, India, South Africa, Tanzania, Thailand, Uganda, Zimbabwe | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01494038 | |||
Other Study ID Numbers ICMJE | P1078 10732 ( Registry Identifier: DAIDS ES ) IMPAACT P1078 |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | National Institute of Allergy and Infectious Diseases (NIAID) | |||
Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | National Institute of Allergy and Infectious Diseases (NIAID) | |||
Verification Date | September 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |