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Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

Primary Purpose

Tuberculosis, HIV Infections

Status
Completed
Phase
Phase 4
Locations
Botswana
Study Type
Interventional
Intervention
Isoniazid
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tuberculosis focused on measuring TB, Tuberculosis, INH, Isoniazid, Preventive therapy, HIV, AIDS, Botswana, LTBI, Latent TB Infection

Eligibility Criteria

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

Inclusion Criteria: HIV-infected Age >=18 years Tuberculin skin test positive or negative Laboratory: Hemoglobin (Hgb) >6.5 gm/dl; Neutrophil count >1,000 cells/mm3; Platelets >75,000/mm3; AST (SGOT) <122 U/L; Creatinine <1.5 mg/dl; Beta HCG = negative Karnofsky performance status >=60 Signed informed consent Exclusion Criteria: History of TB in the last 3 years or current active TB History of noncompliance to chronic therapies

Sites / Locations

  • Gaborone and Francistown Health Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Continuous vs limited isoniazid

Arm Description

The placebo arm will receive 6 months of open label isoniazid before beginning placebo (as a coded medication). The treatment (experimental arm) will receive 6 months of open label isoniazid before beginning coded medication (isoniazid).

Outcomes

Primary Outcome Measures

Incident tuberculosis

Secondary Outcome Measures

Death
Adverse events
After enrolment, half of the participants will receive isoniazid for 6 months and the other half for 36 months.

Full Information

First Posted
September 9, 2005
Last Updated
February 5, 2014
Sponsor
Centers for Disease Control and Prevention
Collaborators
Botswana Ministry of Health, United States Agency for International Development (USAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00164281
Brief Title
Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
Official Title
A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Botswana Ministry of Health, United States Agency for International Development (USAID)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, blinded, two-arm comparative trial of continued versus limited isoniazid (INH) tuberculosis (TB) preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of 36 months.
Detailed Description
Randomized, double blinded, two-arm comparative trial of continuous vs. limited isoniazid preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of 36 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, HIV Infections
Keywords
TB, Tuberculosis, INH, Isoniazid, Preventive therapy, HIV, AIDS, Botswana, LTBI, Latent TB Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous vs limited isoniazid
Arm Type
Experimental
Arm Description
The placebo arm will receive 6 months of open label isoniazid before beginning placebo (as a coded medication). The treatment (experimental arm) will receive 6 months of open label isoniazid before beginning coded medication (isoniazid).
Intervention Type
Drug
Intervention Name(s)
Isoniazid
Other Intervention Name(s)
Isonicotinic Acid Hydrazide
Intervention Description
Daily 300 mg isoniazid supplemented with 25 mg pyridoxine for 6 months vs 36 months.
Primary Outcome Measure Information:
Title
Incident tuberculosis
Time Frame
During enrolment
Secondary Outcome Measure Information:
Title
Death
Time Frame
During enrolment
Title
Adverse events
Description
After enrolment, half of the participants will receive isoniazid for 6 months and the other half for 36 months.
Time Frame
During provision of study medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-infected Age >=18 years Tuberculin skin test positive or negative Laboratory: Hemoglobin (Hgb) >6.5 gm/dl; Neutrophil count >1,000 cells/mm3; Platelets >75,000/mm3; AST (SGOT) <122 U/L; Creatinine <1.5 mg/dl; Beta HCG = negative Karnofsky performance status >=60 Signed informed consent Exclusion Criteria: History of TB in the last 3 years or current active TB History of noncompliance to chronic therapies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taraz Samandari, MD, PHD
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaborone and Francistown Health Clinics
City
Gaborone and Francistown
Country
Botswana

12. IPD Sharing Statement

Citations:
PubMed Identifier
20132624
Citation
Agizew T, Bachhuber MA, Nyirenda S, Makwaruzi VZ, Tedla Z, Tallaksen RJ, Parker JE, Mboya JJ, Samandari T. Association of chest radiographic abnormalities with tuberculosis disease in asymptomatic HIV-infected adults. Int J Tuberc Lung Dis. 2010 Mar;14(3):324-31.
Results Reference
background
PubMed Identifier
20003694
Citation
Agizew TB, Arwady MA, Yoon JC, Nyirenda S, Mosimaneotsile B, Tedla Z, Motsamai O, Kilmarx PH, Wells CD, Samandari T. Tuberculosis in asymptomatic HIV-infected adults with abnormal chest radiographs screened for tuberculosis prevention. Int J Tuberc Lung Dis. 2010 Jan;14(1):45-51.
Results Reference
background
PubMed Identifier
19934764
Citation
Mosimaneotsile B, Mathoma A, Chengeta B, Nyirenda S, Agizew TB, Tedla Z, Motsamai OI, Kilmarx PH, Wells CD, Samandari T. Isoniazid tuberculosis preventive therapy in HIV-infected adults accessing antiretroviral therapy: a Botswana Experience, 2004-2006. J Acquir Immune Defic Syndr. 2010 May 1;54(1):71-7. doi: 10.1097/QAI.0b013e3181c3cbf0.
Results Reference
background
PubMed Identifier
20378730
Citation
Tedla Z, Nyirenda S, Peeler C, Agizew T, Sibanda T, Motsamai O, Vernon A, Wells CD, Samandari T. Isoniazid-associated hepatitis and antiretroviral drugs during tuberculosis prophylaxis in hiv-infected adults in Botswana. Am J Respir Crit Care Med. 2010 Jul 15;182(2):278-85. doi: 10.1164/rccm.200911-1783OC. Epub 2010 Apr 8.
Results Reference
background
PubMed Identifier
21492926
Citation
Samandari T, Agizew TB, Nyirenda S, Tedla Z, Sibanda T, Shang N, Mosimaneotsile B, Motsamai OI, Bozeman L, Davis MK, Talbot EA, Moeti TL, Moffat HJ, Kilmarx PH, Castro KG, Wells CD. 6-month versus 36-month isoniazid preventive treatment for tuberculosis in adults with HIV infection in Botswana: a randomised, double-blind, placebo-controlled trial. Lancet. 2011 May 7;377(9777):1588-98. doi: 10.1016/S0140-6736(11)60204-3. Epub 2011 Apr 12.
Results Reference
result
PubMed Identifier
21541021
Citation
Gust DA, Mosimaneotsile B, Mathebula U, Chingapane B, Gaul Z, Pals SL, Samandari T. Risk factors for non-adherence and loss to follow-up in a three-year clinical trial in Botswana. PLoS One. 2011 Apr 25;6(4):e18435. doi: 10.1371/journal.pone.0018435.
Results Reference
result
PubMed Identifier
22046230
Citation
Chaisson LH, Kass NE, Chengeta B, Mathebula U, Samandari T. Repeated assessments of informed consent comprehension among HIV-infected participants of a three-year clinical trial in Botswana. PLoS One. 2011;6(10):e22696. doi: 10.1371/journal.pone.0022696. Epub 2011 Oct 27.
Results Reference
result
PubMed Identifier
23317952
Citation
Sibanda T, Tedla Z, Nyirenda S, Agizew T, Marape M, Miranda AG, Reuter H, Johnson JL, Samandari T. Anti-tuberculosis treatment outcomes in HIV-infected adults exposed to isoniazid preventive therapy in Botswana. Int J Tuberc Lung Dis. 2013 Feb;17(2):178-85. doi: 10.5588/ijtld.12.0314.
Results Reference
result
PubMed Identifier
23533318
Citation
Taylor AW, Mosimaneotsile B, Mathebula U, Mathoma A, Moathlodi R, Theebetsile I, Samandari T. Pregnancy outcomes in HIV-infected women receiving long-term isoniazid prophylaxis for tuberculosis and antiretroviral therapy. Infect Dis Obstet Gynecol. 2013;2013:195637. doi: 10.1155/2013/195637. Epub 2013 Mar 7.
Results Reference
result
PubMed Identifier
25340318
Citation
Tedla Z, Nguyen ML, Sibanda T, Nyirenda S, Agizew TB, Girde S, Rose CE, Samandari T. Isoniazid-associated hepatitis in adults infected with HIV receiving 36 months of isoniazid prophylaxis in Botswana. Chest. 2015 May;147(5):1376-1384. doi: 10.1378/chest.14-0215.
Results Reference
derived
Links:
URL
http://www.retroconference.org/2010/data/files/webcast_2010.htm
Description
Video webcast of preliminary results by Dr. T. Samandari on Feb 18, 2010

Learn more about this trial

Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

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