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TuberculosisPhase 4NCT00164281

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

A Phase 4 study testing Isoniazid in people with Tuberculosis and HIV Infections, run by Centers for Disease Control and Prevention at 1 site in Botswana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tuberculosis, HIV Infections
What is being tested?
Isoniazid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,995 participants
Where
1 siteBotswana
Study dates
Nov 2004to May 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HIV-infected
  • Age >=18 years
  • Tuberculin skin test positive or negative
  • Laboratory:
  • Hemoglobin (Hgb) >6.5 gm/dl;
  • Neutrophil count >1,000 cells/mm3;
Show all 12Show fewer
  • Platelets >75,000/mm3;
  • AST (SGOT) <122 U/L;
  • Creatinine <1.5 mg/dl;
  • Beta HCG = negative
  • Karnofsky performance status >=60
  • Signed informed consent

Who cannot join

  • History of TB in the last 3 years or current active TB
  • History of noncompliance to chronic therapies

Trial locations and contacts

1 site in 1 country.

Botswana1 site

  • Gaborone and Francistown Health Clinics

    Gaborone

Other trials in Botswana

About this study

Official title: A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

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.

Read the 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.

Being tested
Isoniazid
Keywords
TB, Tuberculosis, INH, Isoniazid, Preventive therapy, HIV, AIDS, Botswana, LTBI, Latent TB Infection
Medical subject headings
Tuberculosis, HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IsoniazidDrug

    Also called Isonicotinic Acid Hydrazide

    Daily 300 mg isoniazid supplemented with 25 mg pyridoxine for 6 months vs 36 months.

Study groups in NCT00164281
Study groupRoleWhat they receive
Continuous isoniazidExperimentalThe treatment (experimental arm) will receive 6 months of open label isoniazid before beginning coded medication (isoniazid).
Receives: Drug: Isoniazid
Limited isoniazid (6 months) + placeboPlacebo comparatorParticipants receive 6 months of open-label isoniazid followed by 30 months of placebo (coded medication).
Receives: Drug: Isoniazid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Incident Tuberculosis

    Incident tuberculosis during follow-up. Tuberculosis cases were categorized as:

    Definite: ≥1 positive culture for M. tuberculosis or ≥2 sputum smears positive for acid-fast bacilli; Probable: 1 sputum smear or biopsy specimen positive for acid-fast bacilli; Possible: clinical diagnosis with negative or unavailable smear/culture results.

    Outcome data include definite, probable, and possible tuberculosis cases combined, consistent with the published analysis.

    Measured: During follow-up (36 months)

Secondary outcomes (2)

  1. Number of Participants Who Died

    All-cause mortality during the 36-month follow-up period.

    Measured: During follow-up (36 months)

  2. Tuberculosis and Death Composite Outcome

    Composite of incident tuberculosis and all deaths during the 36-month follow-up period. The paper presents this as "Tuberculosis and all deaths."

    Measured: During follow-up (36 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionJul 2009
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,995 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00164281
Sponsor's protocol ID
CDC-NCHSTP-3441
Status last verified
May 2026
First submitted
9 Sep 2005
Last updated
27 May 2026
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20132624

  • 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.

    PubMed 20003694

  • 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.

    PubMed 19934764

  • 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.

    PubMed 20378730

  • 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.

    PubMed 21492926

  • 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.

    PubMed 21541021

  • 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.

    PubMed 22046230

  • 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.

    PubMed 23317952

  • 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.

    PubMed 23533318

  • 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.

    PubMed 25340318

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Isoniazid in people with Tuberculosis and HIV Infections, run by Centers for Disease Control and Prevention at 1 site in Botswana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Incident Tuberculosis (time frame: During follow-up (36 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00164281, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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