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

Primary Purpose

Tuberculosis, HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rifapentine (RPT)
Isoniazid (INH)
Pyridoxine (Vitamin B6)
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tuberculosis

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV-1 infection
  • Tuberculin skin test (TST) reactivity greater than or equal to 5 mm or a positive interferon gamma release assay (IGRA) at any time prior to study entry, OR living in a high TB burden area. More information on this criterion can be found in the protocol.

  • Laboratory values obtained within 30 days prior to study entry:

    1. Absolute neutrophil count (ANC) greater than 750 cells/mm^3
    2. Hemoglobin greater than or equal to 7.4 g/dL
    3. Platelet count greater than or equal to 50,000/mm^3
    4. AST (SGOT) and ALT (SGPT) less than or equal to three times the upper limit of normal (ULN)
    5. Total bilirubin less than or equal to 2.5 times the ULN
  • Chest radiograph or chest CT scan without evidence of active tuberculosis, unless one has been performed within 30 days prior to entry
  • Female participants of reproductive potential must have a negative serum or urine pregnancy test performed within 7 days prior to study entry. More information on this criterion can be found in the protocol.
  • All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization) while receiving RPT and for 6 weeks after stopping this drug
  • Female participants who are participating in sexual activity that could lead to pregnancy must agree to use one reliable non-hormonal form of contraceptive while receiving RPT and for 6 weeks after stopping this drug. More information on this criterion can be found in the protocol.
  • Weight of greater than or equal to 30 kg
  • Participant or legal guardian is able and willing to provide informed consent

Exclusion Criteria:

  • Treatment for active or latent TB (pulmonary or extrapulmonary) within 2 years prior to study entry or, at screening, presence of any confirmed or probable TB based on criteria listed in the current ACTG Diagnosis Appendix
  • History of multi-drug resistant (MDR) or extensively-drug resistant (XDR) TB at any time prior to study entry
  • Known exposure to MDR or XDR TB (e.g., household member of a person with MDR or XDR TB) at any time prior to study entry
  • Treatment for more than 14 consecutive days with a rifamycin or more than 30 consecutive days with INH at any time during the 2 years prior to enrollment
  • For participants taking antiretroviral therapy (ART) at study entry, only approved nucleoside reverse transcriptase inhibitors (NRTIs) with efavirenz (EFV) or nevirapine (NVP) for at least 4 weeks were permitted
  • History of liver cirrhosis at any time prior to study entry.
  • Evidence of acute hepatitis, such as abdominal pain, jaundice, dark urine, and/or light stools within 90 days prior to study entry
  • Diagnosis of porphyria at any time prior to study entry
  • Peripheral neuropathy greater than or equal to Grade 2 according to the December 2004 (Clarification, August 2009) Division of AIDS (DAIDS) Toxicity Table, within 90 days prior to study entry
  • Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
  • Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry
  • Breastfeeding

Sites / Locations

  • University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program
  • University of Southern California CRS
  • UCSD Antiviral Research Center CRS
  • Ucsf Hiv/Aids Crs
  • Harbor-UCLA CRS
  • University of Colorado Hospital CRS
  • Denver Public Health CRS
  • The University of Miami AIDS Clinical Research Unit (ACRU) CRS
  • Northwestern University CRS
  • Boston Medical Center CRS
  • Henry Ford Hosp. CRS
  • Cooper Univ. Hosp. CRS
  • New Jersey Medical School Clinical Research Center CRS
  • Bronx-Lebanon Hospital Center NICHD CRS
  • Nyu Ny Nichd Crs
  • Columbia P&S CRS
  • Chapel Hill CRS
  • Duke University Medical Center CRS
  • Trinity Health and Wellness Center CRS
  • Houston AIDS Research Team CRS
  • University of Washington AIDS CRS
  • Gaborone CRS
  • Molepolole CRS
  • Hospital Nossa Senhora da Conceicao CRS
  • Univ. of Sao Paulo Brazil NICHD CRS
  • Hospital Federal dos Servidores do Estado NICHD CRS
  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
  • Hosp. Geral De Nova Igaucu Brazil NICHD CRS
  • Inst de Infectologia Emilio Ribas Sao Paulo Brazil NICHD CRS
  • Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
  • GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS
  • Kisumu Crs
  • Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS
  • Moi University Clinical Research Center (MUCRC) CRS
  • Malawi CRS
  • Blantyre CRS
  • Barranco CRS
  • San Miguel CRS
  • Soweto ACTG CRS
  • Wits Helen Joseph Hospital CRS (Wits HJH CRS)
  • Durban International Clinical Research Site CRS
  • Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
  • Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
  • Chonburi Hosp. CRS
  • Parirenyatwa CRS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RPT plus INH Regimen (Arm A)

INH Regimen (Arm B)

Arm Description

Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.

Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.

Outcomes

Primary Outcome Measures

Incidence of First Diagnosis of Active Tuberculosis, Death Related to Tuberculosis, or Death From Unknown Cause
Incidence rate (events per 100 person-years) was estimated, and 95.1% confidence interval used to account for interim analysis of primary efficacy outcome.

Secondary Outcome Measures

Number of Participants With Occurrence of One or More Serious Adverse Events (SAEs) Versus no SAEs
Occurrence of any SAE that meets the ICH definition of an SAE
Number of Participants With a Targeted Adverse Event
Targeted adverse events include each new grade 3 or 4 laboratory value or sign or symptom that is at least one grade increase from baseline for the following: nausea and vomiting; cutaneous; drug-associated fever; elevated aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]), or bilirubin; and peripheral neuropathy
Number of Participants in Each Category of Ordered Categorical Variable Indicating Most Stringent Level of Study Drug Management Due to Toxicity That Was Required Over the Treatment Period
Ordered categories include: Premature permanent treatment discontinuation Treatment hold for more than 7 consecutive days None of the above
Cumulative Incidence of Death From Any Cause
Data table estimates for percentage who died by each time point were estimated using Kaplan-Meier at 1, 2, 3, and 4 years post-entry.
Cumulative Incidence of Death Due to a Non-TB Event
Cumulative incidence function estimated nonparametrically, treating TB-related deaths as competing risks.
Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis
Among MTB-diagnosed participants who underwent drug-susceptibility testing, the number who had any resistance to a particular drug.
Efavirenz (EFV) Plasma Concentrations in Arm A
Mean and standard deviation. Week 16 samples have not yet been analyzed because the metabolite assay is being validated, and requires submission for approval by the Clinical Pharmacology Quality Assurance Program. Analysis of week 16 samples are anticipated to be available in September 2019.
Nevirapine (NVP) Plasma Concentrations in Arm A
Mean and standard deviation
EFV Plasma Concentrations in Arm B
For Version 2.0 of the protocol only, measured in the first 90 participants randomized to Arm B who enter the study taking EFV and who meet dose timing criteria. Outcome measure was not assessed because no participants enrolled under version 2.0 of the protocol were on Efavirenz at study entry.

Full Information

First Posted
July 26, 2011
Last Updated
November 2, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT01404312
Brief Title
Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)
Official Title
Phase III Clinical Trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Individuals With Latent Tuberculosis Infection
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 23, 2012 (Actual)
Primary Completion Date
November 14, 2017 (Actual)
Study Completion Date
November 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
HIV-infected people have an increased risk of developing active tuberculosis (TB). At the time the study was designed, the standard course of treatment for TB was 6 to 9 months of isoniazid (INH).This study compared the safety and effectiveness of a 4-week regimen of rifapentine (RPT) plus INH versus a standard 9-month regimen of INH in HIV-infected people who are at risk of developing active TB.
Detailed Description
The World Health Organization (WHO) estimated that in 2017 there were 10 million new cases of TB, and 1.6 million people died as a result of TB. Among new TB cases, it is estimated that 920,000 occurred in people who were HIV-coinfected, and 23% of TB deaths were among HIV-coinfected individuals. In Africa, TB is the leading AIDS-related opportunistic infection. Latent TB infection occurs when people are infected with the bacteria that cause TB, but they do not have any symptoms of TB infection. Latent TB can develop into active TB, and HIV-infected people have an increased risk of progressing from latent TB to active TB. INH is a medication that is prescribed for people with latent TB to help prevent active TB from developing. The standard INH treatment regimen is 6 to 9 months; a shorter treatment regimen of 3 months of once-weekly RPT plus INH has proven to be as effective and improved adherence. The purpose of this study was to compare the safety and effectiveness of a 4-week daily regimen of RPT plus INH to a standard 9-month daily INH regimen for TB prevention in HIV-infected individuals. This study enrolled HIV-infected people who did not have evidence of active TB but who were at high risk of developing active TB. Participants were randomly assigned to receive RPT and INH once a day for 4 weeks or INH once a day for 9 months. All participants received pyridoxine (vitamin B6) with each dose of INH to help prevent possible side effects. Study visits occurred at baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 36. At select study visits, participants had a physical exam, clinical assessment, blood collection, and a chest radiograph or chest computed tomography (CT) scan (if needed). Some participants had their blood stored for future testing. Follow-up study visits occurred every 12 weeks starting at Week 48 and continued for 3 years after the last participant enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, HIV Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RPT plus INH Regimen (Arm A)
Arm Type
Experimental
Arm Description
Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.
Arm Title
INH Regimen (Arm B)
Arm Type
Active Comparator
Arm Description
Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.
Intervention Type
Drug
Intervention Name(s)
Rifapentine (RPT)
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Isoniazid (INH)
Intervention Description
Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pyridoxine (Vitamin B6)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of First Diagnosis of Active Tuberculosis, Death Related to Tuberculosis, or Death From Unknown Cause
Description
Incidence rate (events per 100 person-years) was estimated, and 95.1% confidence interval used to account for interim analysis of primary efficacy outcome.
Time Frame
From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Secondary Outcome Measure Information:
Title
Number of Participants With Occurrence of One or More Serious Adverse Events (SAEs) Versus no SAEs
Description
Occurrence of any SAE that meets the ICH definition of an SAE
Time Frame
From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Title
Number of Participants With a Targeted Adverse Event
Description
Targeted adverse events include each new grade 3 or 4 laboratory value or sign or symptom that is at least one grade increase from baseline for the following: nausea and vomiting; cutaneous; drug-associated fever; elevated aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]), or bilirubin; and peripheral neuropathy
Time Frame
From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Title
Number of Participants in Each Category of Ordered Categorical Variable Indicating Most Stringent Level of Study Drug Management Due to Toxicity That Was Required Over the Treatment Period
Description
Ordered categories include: Premature permanent treatment discontinuation Treatment hold for more than 7 consecutive days None of the above
Time Frame
From entry to end of treatment (up to 8 weeks for Arm A; up to 54 weeks for Arm B)
Title
Cumulative Incidence of Death From Any Cause
Description
Data table estimates for percentage who died by each time point were estimated using Kaplan-Meier at 1, 2, 3, and 4 years post-entry.
Time Frame
From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Title
Cumulative Incidence of Death Due to a Non-TB Event
Description
Cumulative incidence function estimated nonparametrically, treating TB-related deaths as competing risks.
Time Frame
From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Title
Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis
Description
Among MTB-diagnosed participants who underwent drug-susceptibility testing, the number who had any resistance to a particular drug.
Time Frame
After TB diagnosis
Title
Efavirenz (EFV) Plasma Concentrations in Arm A
Description
Mean and standard deviation. Week 16 samples have not yet been analyzed because the metabolite assay is being validated, and requires submission for approval by the Clinical Pharmacology Quality Assurance Program. Analysis of week 16 samples are anticipated to be available in September 2019.
Time Frame
Measured at Weeks 0, 2, 4, and 16
Title
Nevirapine (NVP) Plasma Concentrations in Arm A
Description
Mean and standard deviation
Time Frame
Measured at Weeks 0, 2, and 4
Title
EFV Plasma Concentrations in Arm B
Description
For Version 2.0 of the protocol only, measured in the first 90 participants randomized to Arm B who enter the study taking EFV and who meet dose timing criteria. Outcome measure was not assessed because no participants enrolled under version 2.0 of the protocol were on Efavirenz at study entry.
Time Frame
Measured at weeks 0, 2 and 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-1 infection Tuberculin skin test (TST) reactivity greater than or equal to 5 mm or a positive interferon gamma release assay (IGRA) at any time prior to study entry, OR living in a high TB burden area. More information on this criterion can be found in the protocol. Laboratory values obtained within 30 days prior to study entry: Absolute neutrophil count (ANC) greater than 750 cells/mm^3 Hemoglobin greater than or equal to 7.4 g/dL Platelet count greater than or equal to 50,000/mm^3 AST (SGOT) and ALT (SGPT) less than or equal to three times the upper limit of normal (ULN) Total bilirubin less than or equal to 2.5 times the ULN Chest radiograph or chest CT scan without evidence of active tuberculosis, unless one has been performed within 30 days prior to entry Female participants of reproductive potential must have a negative serum or urine pregnancy test performed within 7 days prior to study entry. More information on this criterion can be found in the protocol. All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization) while receiving RPT and for 6 weeks after stopping this drug Female participants who are participating in sexual activity that could lead to pregnancy must agree to use one reliable non-hormonal form of contraceptive while receiving RPT and for 6 weeks after stopping this drug. More information on this criterion can be found in the protocol. Weight of greater than or equal to 30 kg Participant or legal guardian is able and willing to provide informed consent Exclusion Criteria: Treatment for active or latent TB (pulmonary or extrapulmonary) within 2 years prior to study entry or, at screening, presence of any confirmed or probable TB based on criteria listed in the current ACTG Diagnosis Appendix History of multi-drug resistant (MDR) or extensively-drug resistant (XDR) TB at any time prior to study entry Known exposure to MDR or XDR TB (e.g., household member of a person with MDR or XDR TB) at any time prior to study entry Treatment for more than 14 consecutive days with a rifamycin or more than 30 consecutive days with INH at any time during the 2 years prior to enrollment For participants taking antiretroviral therapy (ART) at study entry, only approved nucleoside reverse transcriptase inhibitors (NRTIs) with efavirenz (EFV) or nevirapine (NVP) for at least 4 weeks were permitted History of liver cirrhosis at any time prior to study entry. Evidence of acute hepatitis, such as abdominal pain, jaundice, dark urine, and/or light stools within 90 days prior to study entry Diagnosis of porphyria at any time prior to study entry Peripheral neuropathy greater than or equal to Grade 2 according to the December 2004 (Clarification, August 2009) Division of AIDS (DAIDS) Toxicity Table, within 90 days prior to study entry Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry Breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard E. Chaisson, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Susan Swindells, MBBS
Organizational Affiliation
University of Nebraska
Official's Role
Study Chair
Facility Information:
Facility Name
University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0672
Country
United States
Facility Name
University of Southern California CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-1079
Country
United States
Facility Name
UCSD Antiviral Research Center CRS
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Ucsf Hiv/Aids Crs
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Harbor-UCLA CRS
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
University of Colorado Hospital CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Denver Public Health CRS
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
The University of Miami AIDS Clinical Research Unit (ACRU) CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Boston Medical Center CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Henry Ford Hosp. CRS
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Cooper Univ. Hosp. CRS
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
New Jersey Medical School Clinical Research Center CRS
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Bronx-Lebanon Hospital Center NICHD CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Nyu Ny Nichd Crs
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia P&S CRS
City
New York
State/Province
New York
ZIP/Postal Code
10032-3732
Country
United States
Facility Name
Chapel Hill CRS
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Trinity Health and Wellness Center CRS
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
Houston AIDS Research Team CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington AIDS CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104-9929
Country
United States
Facility Name
Gaborone CRS
City
Gaborone
Country
Botswana
Facility Name
Molepolole CRS
City
Gaborone
Country
Botswana
Facility Name
Hospital Nossa Senhora da Conceicao CRS
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Univ. of Sao Paulo Brazil NICHD CRS
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil
Facility Name
Hospital Federal dos Servidores do Estado NICHD CRS
City
Rio de Janeiro
ZIP/Postal Code
20221-903
Country
Brazil
Facility Name
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
City
Rio de Janeiro
ZIP/Postal Code
21040-360
Country
Brazil
Facility Name
Hosp. Geral De Nova Igaucu Brazil NICHD CRS
City
Rio de Janeiro
ZIP/Postal Code
26030
Country
Brazil
Facility Name
Inst de Infectologia Emilio Ribas Sao Paulo Brazil NICHD CRS
City
Sao Paulo
ZIP/Postal Code
01246-900
Country
Brazil
Facility Name
Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
City
Port-au-Prince
ZIP/Postal Code
6110
Country
Haiti
Facility Name
GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS
City
Port-au-Prince
Country
Haiti
Facility Name
Kisumu Crs
City
Kisumu
State/Province
Nyanza
ZIP/Postal Code
40100
Country
Kenya
Facility Name
Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS
City
Kericho
State/Province
Rift Valley
ZIP/Postal Code
20200
Country
Kenya
Facility Name
Moi University Clinical Research Center (MUCRC) CRS
City
Eldoret
ZIP/Postal Code
30100
Country
Kenya
Facility Name
Malawi CRS
City
Lilongwe
State/Province
Central
Country
Malawi
Facility Name
Blantyre CRS
City
Blantyre
Country
Malawi
Facility Name
Barranco CRS
City
Lima
ZIP/Postal Code
04
Country
Peru
Facility Name
San Miguel CRS
City
Lima
ZIP/Postal Code
32
Country
Peru
Facility Name
Soweto ACTG CRS
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1862
Country
South Africa
Facility Name
Wits Helen Joseph Hospital CRS (Wits HJH CRS)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2092
Country
South Africa
Facility Name
Durban International Clinical Research Site CRS
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4013
Country
South Africa
Facility Name
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Chonburi Hosp. CRS
City
Chon Buri
ZIP/Postal Code
20000
Country
Thailand
Facility Name
Parirenyatwa CRS
City
Harare
Country
Zimbabwe

12. IPD Sharing Statement

Citations:
PubMed Identifier
19525621
Citation
Golub JE, Pronyk P, Mohapi L, Thsabangu N, Moshabela M, Struthers H, Gray GE, McIntyre JA, Chaisson RE, Martinson NA. Isoniazid preventive therapy, HAART and tuberculosis risk in HIV-infected adults in South Africa: a prospective cohort. AIDS. 2009 Mar 13;23(5):631-6. doi: 10.1097/QAD.0b013e328327964f.
Results Reference
background
PubMed Identifier
19729664
Citation
Zhang T, Zhang M, Rosenthal IM, Grosset JH, Nuermberger EL. Short-course therapy with daily rifapentine in a murine model of latent tuberculosis infection. Am J Respir Crit Care Med. 2009 Dec 1;180(11):1151-7. doi: 10.1164/rccm.200905-0795OC. Epub 2009 Sep 3.
Results Reference
background
PubMed Identifier
35943252
Citation
Pham MM, Podany AT, Mwelase N, Supparatpinyo K, Mohapi L, Gupta A, Samaneka W, Omoz-Oarhe A, Langat D, Benson CA, Chaisson RE, Swindells S, Fletcher CV. Population Pharmacokinetic Modeling and Simulation of Rifapentine Supports Concomitant Antiretroviral Therapy with Efavirenz and Non-Weight Based Dosing. Antimicrob Agents Chemother. 2022 Sep 20;66(9):e0238521. doi: 10.1128/aac.02385-21. Epub 2022 Aug 9.
Results Reference
derived
PubMed Identifier
32815870
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https://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf
Description
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URL
http://rsc.tech-res.com/docs/default-source/safety/manual_for_expedited_reporting_aes_to_daids_v2.pdf?sfvrsn=12
Description
Manual for Expedited Reporting of Adverse Events to DAIDS

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

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