Evaluating the Safety and Effectiveness of Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Individuals With Latent Tuberculosis Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01404312
First received: July 26, 2011
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

HIV-infected people have an increased risk of developing active tuberculosis (TB). The standard course of treatment for TB is 6 to 9 months of isoniazid (INH). A shorter course of treatment may be as effective and potentially increase treatment adherence. This study will compare 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.


Condition Intervention Phase
Tuberculosis
HIV Infections
Drug: Rifapentine (RPT)
Drug: Isoniazid (INH)
Dietary Supplement: Pyridoxine (Vitamin B6)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Time from randomization to first diagnosis of active TB [ Time Frame: Measured through participants' last follow-up visit (3 years after last participant is enrolled) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of one or more serious adverse events (SAEs) versus no SAEs [ Time Frame: Measured through participants' last follow-up visit (3 years after last participant is enrolled) ] [ Designated as safety issue: Yes ]
  • Highest reported grade of each new Grade 3 or 4 laboratory value or sign or symptom that is at least one grade increase from baseline for targeted events [ Time Frame: Measured through participants' last follow-up visit (3 years after last participant is enrolled) ] [ Designated as safety issue: Yes ]
    Examples include: 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

  • Ordered categorical variable indicating most stringent level of study drug management due to toxicity that was required over the treatment period [ Time Frame: Measured through participants' last follow-up visit (3 years after last participant is enrolled) ] [ Designated as safety issue: No ]

    Ordered categorical variables include:

    1. Premature permanent treatment discontinuation
    2. Treatment hold for more than 7 consecutive days
    3. None of the above

  • Time from randomization to death from any cause [ Time Frame: Measured through participants' last follow-up visit (3 years after last participant is enrolled) ] [ Designated as safety issue: No ]
  • Time from randomization to death due to a non-TB event [ Time Frame: Measured through participants' last follow-up visit (3 years after last participant is enrolled) ] [ Designated as safety issue: No ]
  • Efavirenz (EFV) plasma concentrations at Weeks 2 and 4 [ Time Frame: Measured at Weeks 2 and 4 ] [ Designated as safety issue: No ]
    Only measured in the first 90 participants who enter the study taking EFV and who meet dose timing criteria

  • Nevirapine (NVP) plasma concentrations at Weeks 2 and 4 [ Time Frame: Measured at Weeks 2 and 4 ] [ Designated as safety issue: No ]
    Only measured in the first 90 participants who enter the study taking NVP and who meet dose timing criteria

  • Adherence to TB treatment [ Time Frame: Measured through Week 36 ] [ Designated as safety issue: No ]
    Self-reported number of pills missed since last visit and pill count while on study drug

  • Antibiotic resistance pattern of Mycobacterium tuberculosis (MTB) isolates in participants who develop active TB [ Time Frame: Measured through participants' last follow-up visit (3 years after last participant is enrolled) ] [ Designated as safety issue: No ]
  • HIV-1 RNA changes from baseline to Week 8 [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
    Measured in the first 90 participants entering the study taking EFV and who meet pharmacokinetic (PK) analysis dose timing criteria and in the first 90 participants entering the study taking NVP and who meet PK analysis dose timing criteria (may be evaluated only in a subset, e.g., those with very low EFV or NVP levels)

  • Polymorphisms in host genes involved in metabolism or transport of EFV, NVP, and RPT [ Time Frame: Measured through participants' last follow-up visit (3 years after last participant is enrolled) ] [ Designated as safety issue: No ]
    Polymorphisms include: CYP2B6, CYP3A4/5, SLCO1B1, CYP2A6, UGT2B7, PXR (pregnane X receptor), CAR (constitutive androstane receptor), and HNF4A (hepatocyte nuclear factor)

  • Cost-effectiveness measures [ Time Frame: Measured through participants' last follow-up visit (3 years after last participant is enrolled) ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: May 2012
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RPT plus INH Regimen (Arm A)
Participants will receive 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 will not receive any study medications.
Drug: Rifapentine (RPT)

RPT dosing will be based on participants' weight:

Participants who weigh 30 kg to less than 35 kg will receive 300 mg once daily (administered as two 150-mg tablets).

Participants who weigh 35 kg to less than 45 kg will receive 450 mg once daily (administered as three 150-mg tablets).

Participants who weigh greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).

Drug: Isoniazid (INH)
Participants will receive one 300-mg tablet or three 100-mg tablets of INH once daily.
Dietary Supplement: Pyridoxine (Vitamin B6)

Participants will receive 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine will take one 25-mg tablet once daily with INH.

Participants receiving 50 mg of pyridoxine will take two 25-mg tablets once daily with INH.

Active Comparator: INH Regimen (Arm B)
Participants will receive 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.
Drug: Isoniazid (INH)
Participants will receive one 300-mg tablet or three 100-mg tablets of INH once daily.
Dietary Supplement: Pyridoxine (Vitamin B6)

Participants will receive 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine will take one 25-mg tablet once daily with INH.

Participants receiving 50 mg of pyridoxine will take two 25-mg tablets once daily with INH.


Detailed Description:

The World Health Organization (WHO) estimates that in 2009 there were 9.4 million new cases of TB, and 1.68 million people died as a result of TB. Among new TB cases, 1.1 million occurred in people who were HIV-coinfected, and 35% 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 may prove to be as effective and may improve adherence. The purpose of this study is 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 will enroll HIV-infected people who do not have evidence of active TB but who are at high risk of developing active TB. Participants will be randomly assigned to receive RPT and INH once a day for 4 weeks or INH once a day for 9 months. All participants will receive pyridoxine (vitamin B6) with each dose of INH to help prevent possible side effects. Study visits will occur at baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 36. At select study visits, participants will undergo a physical exam, clinical assessment, blood collection, and a chest radiograph (if needed). Some participants will have their blood stored for future testing. Follow-up study visits will occur every 12 weeks starting at Week 48 and will continue for 3 years after the last participant is enrolled.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load. More information on this criterion can be found in the protocol.
  • 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
  • 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 (i.e., condoms, intrauterine device [IUD]), diaphragm with spermicide, or cervical cap with spermicide) 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), only approved nucleoside reverse transcriptase inhibitor (NRTI)- and non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens will be allowed at study entry and during the first 4 weeks of study treatment with RPT; a list of approved NRTIs and NNRTIs is located on the A5279 protocol-specific webpage. Treatment with any other ART regimen (e.g., protease inhibitor [PI]-based, raltegravir-containing) at study entry or plans to initiate such a regimen during the first 4 weeks of study treatment is exclusionary. Participants must have been on their current ART regimen for at least 4 weeks. NOTE: Participants taking NVP will not be eligible to enroll until the protocol team has reviewed the PK data on those participants taking EFV and determined that it is safe to enroll participants taking NVP. The team will send a memo to sites notifying them if and when participants taking NVP are eligible to enroll.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404312

  Hide Study Locations
Locations
United States, California
Usc La Nichd Crs Withdrawn
Alhambra, California, United States, 91803
University of California, UC San Diego CRS Recruiting
La Jolla, California, United States, 92093-0672
Contact: Kimberly Norris, B.S.N., R.N.    858-534-9204    kanorris@ucsd.edu   
UCLA CARE Center CRS Not yet recruiting
Los Angeles, California, United States, 90035
Contact: Arezou S. Akha    310-557-3798    asadighi@mednet.ucla.edu   
University of Southern California CRS Recruiting
Los Angeles, California, United States, 90033-1079
Contact: Luis M. Mendez    323-343-8283    lmendez@usc.edu   
UCSD Antiviral Research Center CRS Recruiting
San Diego, California, United States, 92103
Contact: Jill Kunkel    619-543-8080    jkunkel@ucsd.edu   
Ucsf Hiv/Aids Crs Recruiting
San Francisco, California, United States, 94110
Contact: Jay Dwyer    415-476-4082 ext 353    jdwyer@php.ucsf.edu   
Harbor-UCLA CRS Recruiting
Torrance, California, United States, 90502
Contact: Mario Guerrero    424-201-3000 ext 7318    mguerrero@labiomed.org   
United States, Colorado
University of Colorado Hospital CRS Recruiting
Aurora, Colorado, United States, 80045
Contact: Mary Graham Ray, RN, MSN    303-724-0712    graham.ray@ucdenver.edu   
Univ. of Colorado Denver NICHD CRS Withdrawn
Aurora, Colorado, United States, 80045
Denver Public Health CRS Recruiting
Denver, Colorado, United States, 80204
Contact: James A. Scott, A.C.R.N., B.S.N.    303-602-8741    James.Scott@dhha.org   
United States, Florida
South Florida CDTC Ft Lauderdale NICHD CRS Withdrawn
Fort Lauderdale, Florida, United States, 33316
The University of Miami AIDS Clinical Research Unit (ACRU) CRS Recruiting
Miami, Florida, United States, 33136
Contact: Lillian Colon, RN, BSN    305-243-3838    LColon2@med.miami.edu   
USF - Tampa NICHD CRS Withdrawn
Tampa, Florida, United States, 33606
United States, Georgia
The Ponce de Leon Center CRS Not yet recruiting
Atlanta, Georgia, United States, 30308-2012
Contact: Ericka Patrick    404-616-6313    erpatri@emory.edu   
United States, Illinois
Rush University CRS Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Janice Fritsche, MS    312-942-4810    Janice_Fritsche@rush.edu   
Northwestern University CRS Recruiting
Chicago, Illinois, United States, 60611
Contact: Baiba Berzins    312-695-5012    baiba@northwestern.edu   
United States, Maryland
IHV Baltimore Treatment CRS Withdrawn
Baltimore, Maryland, United States, 21201
Johns Hopkins University CRS Not yet recruiting
Baltimore, Maryland, United States, 21205
Contact: Ilene Wiggins, R.N.    410-614-2766    iwiggin1@jhmi.edu   
United States, Massachusetts
Beth Israel Deaconess Med. Ctr., ACTG CRS Withdrawn
Boston, Massachusetts, United States, 02215
Bmc Actg Crs Completed
Boston, Massachusetts, United States, 02118
Boston Medical Center Ped. HIV Program NICHD CRS Withdrawn
Boston, Massachusetts, United States, 02118
United States, Michigan
Henry Ford Hosp. CRS Recruiting
Detroit, Michigan, United States, 48202
Contact: Linda Makohon, RN, BSN    313-916-2570    lmakoho1@hfhs.org   
Wayne State Univ. CRS Withdrawn
Detroit, Michigan, United States, 48201
United States, New Jersey
Cooper Univ. Hosp. CRS Completed
Camden, New Jersey, United States, 08103
New Jersey Medical School- Adult Clinical Research Ctr. CRS Withdrawn
Newark, New Jersey, United States, 07103
New Jersey Medical School Clinical Research Center CRS Recruiting
Newark, New Jersey, United States, 07103
Contact: Janet Forcht, R.N.    973-972-1005    janet.forcht@rutgers.edu   
United States, New York
Bronx-Lebanon Hosp. Ctr. CRS Not yet recruiting
Bronx, New York, United States, 10457
Contact: Luz Marina Vasco    718-960-1016    lvasco@bronxleb.org   
Bronx-Lebanon CRS Withdrawn
Bronx, New York, United States, 10457
Bronx-Lebanon Hospital Center NICHD CRS Recruiting
Bronx, New York, United States, 10457
Contact: Rita Sondengam, M.P.H.    718-960-1010    rsondeng@bronxleb.org   
Nyu Ny Nichd Crs Recruiting
New York, New York, United States, 10016
Contact: Sandra Deygoo, BS    212-263-5680    deygos01@med.nyu.edu   
Columbia P&S CRS Recruiting
New York, New York, United States, 10032-3732
Contact: Steven Palmer, P.A. -C    212-342-2958    sp500@cumc.columbia.edu   
SUNY Stony Brook NICHD CRS Not yet recruiting
Stony Brook, New York, United States, 11794-8111
Contact: Denise Ferraro    631-444-8225    denise.ferraro@stonybrook.edu   
United States, North Carolina
Chapel Hill CRS Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Susan Pedersen    919-966-6713    spederse@med.unc.edu   
Duke Univ. Med. Ctr. Adult CRS Completed
Durham, North Carolina, United States, 27710
DUMC Ped. CRS Withdrawn
Durham, North Carolina, United States, 27710
United States, Texas
Trinity Health and Wellness Center CRS Recruiting
Dallas, Texas, United States, 75208
Contact: Michelle Mba, MPH    972-807-7370 ext 4420    Michelle.Mba@aidsarms.org   
Houston AIDS Research Team CRS Recruiting
Houston, Texas, United States, 77030
Contact: Maria L. Martinez    713-500-6718    Maria.L.Martinez@uth.tmc.edu   
United States, Washington
University of Washington AIDS CRS Recruiting
Seattle, Washington, United States, 98104-9929
Contact: Christine Jonsson    206-744-8886    cjonsson@u.washington.edu   
Seattle Children's Research Institute CRS Withdrawn
Seattle, Washington, United States, 98101
Botswana
Gaborone CRS Recruiting
Gaborone, Botswana
Contact: Tebogo Kakhu    267-3931353    tkakhu@bhp.org.bw   
Molepolole CRS Recruiting
Gaborone, Botswana
Contact: Ayotunde Omoz-Oarhe, MDCM    267-3910388    aomozooarhe@bhp.org.bw   
Brazil
SOM Federal University Minas Gerais Brazil NICHD CRS Not yet recruiting
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Contact: Fabiana Kakehasi, M.D.    55-31-34099111    kakehasi@medicina.ufmg.br   
Hospital Nossa Senhora da Conceicao CRS Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
Contact: Rita d. Lira, M.D.    55-51-33572603    Lrita@ghc.com.br   
Hosp. dos Servidores Rio de Janeiro NICHD CRS Recruiting
Rio de Janeiro, Brazil, 20221-903
Contact: Leon C. Sidi, M.D.    55-21-22330018    leon@diphse.com.br   
Hosp. Geral De Nova Igaucu Brazil NICHD CRS Recruiting
Rio de Janeiro, Brazil, 26030
Contact: Gisely G. Falco    55-21-26676059    gisely.falco@gmail.com   
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS Recruiting
Rio de Janeiro, Brazil, 21040-360
Contact: Sandra W. Cardoso, MD    55-21-22707064    sandra.wagner@ipec.fiocruz.br   
Inst de Infectologia Emilio Ribas Sao Paulo Brazil NICHD CRS Recruiting
Sao Paulo, Brazil, 01246-900
Contact: Paula P. Barbosa, M.S.    55-11-30612521    aacphiv@uol.com.br   
Univ. of Sao Paulo Brazil NICHD CRS Not yet recruiting
Sao Paulo, Brazil, 14049-900
Contact: Adriana A. Barbaro    55-1632345516    a.tiraboschi@uol.com.br   
Haiti
Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS Recruiting
Port-au-Prince, Haiti, 6110
Contact: Cynthia Riviere, MD    509-22222241    criviere@gheskio.org   
GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS Recruiting
Port-au-Prince, Haiti
Contact: Sandy N. Nerette       snerette@gheskio.org   
India
Chennai Antiviral Research and Treatment (CART) CRS Not yet recruiting
Chennai, Tamil Nadu, India, 600113
Contact: Faith E. Beulah    91-44-39106811    Beulah@yrgcare.org   
Kenya
Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS Recruiting
Kericho, Rift Valley, Kenya, 20200
Contact: Samwel K. Chirchir    254-5230686    Samwel.Chirchir@usamru-k.org   
Moi University Clinical Research Center (MUCRC) CRS Recruiting
Eldoret, Uasin Gishu, Kenya, 30100
Contact: Priscilla C. Cheruiyot    254-532060850    pcchepkorir@yahoo.com   
KEMRI/CDC Research and Public Health Collaboration (KEMRI/CDC) CRS Not yet recruiting
Kisumu, Kenya, 40100
Contact: Elisha Okeyo    254-721410654    eokeyo@kemricdc.org   
Malawi
Blantyre CRS Recruiting
Blantyre, Malawi
Contact: Leslie Degnan, MPH    265-1874885 ext 202    ldegnan@jhsph.edu   
Malawi CRS Recruiting
Lilongwe, Central, Malawi
Contact: Deborah D. Kamwendo    265-888-251778    kamwendo@email.unc.edu   
Peru
Barranco CRS Recruiting
Lima, Peru, 04
Contact: Pedro Gonzales, M.D., M.A.S.    51-1-2067800 ext 402    pgonzales@impactaperu.org   
San Miguel CRS Recruiting
Lima, Peru, 32
Contact: Jessica Rios, R.N.    51-1-5621600 ext 119    jrios@impactaperu.org   
Puerto Rico
Puerto Rico AIDS Clinical Trials Unit CRS Not yet recruiting
San Juan, Puerto Rico, 00935
Contact: Sylvia I. Davila Nieves, MS    787-767-9192    sylvia.davila@upr.edu   
San Juan City Hosp. PR NICHD CRS Withdrawn
San Juan,, Puerto Rico, 00936
South Africa
Wits Helen Joseph Hospital CRS (Wits HJH CRS) Recruiting
Johannesburg, Gauteng, South Africa, 2092
Contact: Pauline Vunandlala, RN    27-11-2768839    pvunandlala@witshealth.co.za   
Soweto ACTG CRS Recruiting
Johannesburg, Gauteng, South Africa, 1864
Contact: Maureen M. Mohata    27-11-9899700    mohatam@phru.co.za   
Durban International Clinical Research Site CRS Recruiting
Durban, KwaZulu-Natal, South Africa, 4013
Contact: Rosie Mngqibisa, MBBS    27-31-5663933    mngqibisa@ecarefoundation.com   
eThekwini CRS Not yet recruiting
Durban, KwaZulu-Natal, South Africa, 4001
Contact: Kalendri Naidoo    27-31-2601956    naidook3@ukzn.ac.za   
Tanzania
Kilimanjaro Christian Medical Center CRS Withdrawn
Moshi, Tanzania
Thailand
Siriraj Hospital ,Mahidol University NICHD CRS Not yet recruiting
Bangkok, Bangkoknoi, Thailand, 10700
Contact: Watcharee Lermankul    66-2-419 7000 ext 5695    watchareeped@gmail.com   
Siriraj Hospital Mahidol University CRS Not yet recruiting
Bangkok, Bangkoknoi, Thailand, 10700
Contact: Sirintip Sricharoenchai, MD    66-2-8660944    sirintipsri@gmail.com   
Chiang Mai University Pediatrics-Obstetrics CRS Withdrawn
Chiang Mai, Thailand, 50200
Chiang Mai Univ. ACTG CRS Withdrawn
Chiang Mai, Thailand, 50200
Institut de Recherche pour Developpement (IRD) - PHPT CRS Not yet recruiting
Chiang Mai, Thailand, 50100
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS Recruiting
Chiang Mai, Thailand, 50200
Contact: Daralak Tavornprasit, RN, MSc    66-898507866    daralak@rihes.org   
Chonburi Hosp. CRS Recruiting
Chonburi, Thailand, 20000
Contact: Ladda Argadamnuy    66-38-931000    ladda.argad@gmail.com   
Uganda
Joint Clinical Research Center (JCRC)/Kampala CRS Not yet recruiting
Kampala, Uganda
Contact: Sandra Rwambuya, M.P.H.    256-41-4342521    dxr23@case.edu   
Zambia
Kalingalinga Clinic CRS Not yet recruiting
Lusaka, Zambia, 10101
Contact: Manze Chinyama    260-977870158    Manze.chinyama@cidrz.org   
Zimbabwe
Parirenyatwa CRS Recruiting
Harare, Zimbabwe
Contact: Rachel Mahachi    263-4-701356    rmahachi@uzcrc.co.zw   
Sponsors and Collaborators
Investigators
Study Chair: Richard E. Chaisson, MD Johns Hopkins University
Study Chair: Susan Swindells, MBBS University of Nebraska
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01404312     History of Changes
Other Study ID Numbers: A5279, 10848, ACTG A5279
Study First Received: July 26, 2011
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Tuberculosis
Latent Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Isoniazid
Rifapentine
Pyridoxine
Vitamin B 6
Pyridoxal
Vitamin B Complex
Vitamins
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014