Evaluating the Safety of Immediate Versus Deferred Isoniazid Preventive Therapy Among HIV-Infected Pregnant Women

PHASE4CompletedINTERVENTIONAL
Enrollment

956

Participants

Timeline

Start Date

August 19, 2014

Primary Completion Date

September 6, 2017

Study Completion Date

September 6, 2017

Conditions
HIV InfectionsTuberculosis
Interventions
DRUG

Isoniazid (INH)

300-mg tablet once daily by mouth, either from entry through Week 28 antepartum (Arm A) or from Week 12 postpartum through Week 40 postpartum (Arm B)

DRUG

Placebo for isoniazid (INH)

Placebo tablet once daily by mouth, either from Week 28 visit through Week 40 postpartum (Arm A) or from entry until Week 12 postpartum visit (Arm B)

Trial Locations (13)

1862

Soweto IMPAACT CRS, Johannesburg

7505

Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS, Cape Town

Fam-Cru Crs, Cape Town

50200

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS, Chiang Mai

411001

Byramjee Jeejeebhoy Medical College (BJMC) CRS, Pune

Unknown

Gaborone CRS, Gaborone

Molepolole CRS, Gaborone

Kilimanjaro Christian Medical Centre (KCMC), Moshi

MU-JHU Research Collaboration (MUJHU CARE LTD) CRS, Kampala

Seke North CRS, Chitungwiza

St Mary's CRS, Chitungwiza

Harare Family Care CRS, Harare

HT-6110

Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS, Port-au-Prince

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01494038 - Evaluating the Safety of Immediate Versus Deferred Isoniazid Preventive Therapy Among HIV-Infected Pregnant Women | Biotech Hunter | Biotech Hunter