Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)

PHASE3CompletedINTERVENTIONAL
Enrollment

3,000

Participants

Timeline

Start Date

May 23, 2012

Primary Completion Date

November 14, 2017

Study Completion Date

November 14, 2017

Conditions
TuberculosisHIV Infections
Interventions
DRUG

Rifapentine (RPT)

"RPT dosing was be based on participants' weight:~Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).~Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).~Participants who weighed greater than 45 kg received 600 mg once daily (administered as four 150-mg tablets)."

DRUG

Isoniazid (INH)

Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

DIETARY_SUPPLEMENT

Pyridoxine (Vitamin B6)

"Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.~Participants who received 25 mg of pyridoxine took one 25-mg tablet once daily with INH.~Participants who received 50 mg of pyridoxine took two 25-mg tablets once daily with INH."

Trial Locations (45)

32

San Miguel CRS, Lima

1862

Soweto ACTG CRS, Johannesburg

2092

Wits Helen Joseph Hospital CRS (Wits HJH CRS), Johannesburg

4013

Durban International Clinical Research Site CRS, Durban

6110

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

10016

Nyu Ny Nichd Crs, New York

10330

Thai Red Cross AIDS Research Centre (TRC-ARC) CRS, Bangkok

10457

Bronx-Lebanon Hospital Center NICHD CRS, The Bronx

20000

Chonburi Hosp. CRS, Chon Buri

20200

Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS, Kericho

26030

Hosp. Geral De Nova Igaucu Brazil NICHD CRS, Rio de Janeiro

27599

Chapel Hill CRS, Chapel Hill

27710

Duke University Medical Center CRS, Durham

30100

Moi University Clinical Research Center (MUCRC) CRS, Eldoret

33136

The University of Miami AIDS Clinical Research Unit (ACRU) CRS, Miami

40100

Kisumu Crs, Kisumu

48202

Henry Ford Hosp. CRS, Detroit

50200

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

60611

Northwestern University CRS, Chicago

75208

Trinity Health and Wellness Center CRS, Dallas

77030

Houston AIDS Research Team CRS, Houston

80045

University of Colorado Hospital CRS, Aurora

80204

Denver Public Health CRS, Denver

90502

Harbor-UCLA CRS, Torrance

92103

UCSD Antiviral Research Center CRS, San Diego

94110

Ucsf Hiv/Aids Crs, San Francisco

92093-0672

University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program, La Jolla

90033-1079

University of Southern California CRS, Los Angeles

02118

Boston Medical Center CRS, Boston

08103

Cooper Univ. Hosp. CRS, Camden

07103

New Jersey Medical School Clinical Research Center CRS, Newark

10032-3732

Columbia P&S CRS, New York

98104-9929

University of Washington AIDS CRS, Seattle

Unknown

Gaborone CRS, Gaborone

Molepolole CRS, Gaborone

GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS, Port-au-Prince

Malawi CRS, Lilongwe

Blantyre CRS, Blantyre

Parirenyatwa CRS, Harare

91350-200

Hospital Nossa Senhora da Conceicao CRS, Porto Alegre

14049-900

Univ. of Sao Paulo Brazil NICHD CRS, São Paulo

20221-903

Hospital Federal dos Servidores do Estado NICHD CRS, Rio de Janeiro

21040-360

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS, Rio de Janeiro

01246-900

Inst de Infectologia Emilio Ribas Sao Paulo Brazil NICHD CRS, São Paulo

04

Barranco CRS, Lima

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01404312 - Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB) | Biotech Hunter | Biotech Hunter