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AzTrials

Human Immunodeficiency VirusPhase 3NCT00351702

Preventive Therapy for Tuberculosis in HIV Infected Persons

A Phase 3 study testing Isoniazid with Ethambutol in people with Human Immunodeficiency Virus and Tuberculosis, run by Tuberculosis Research Centre, India at 1 site in India.

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

Title: Evaluation of efficacy of two different preventive therapy regimens for tuberculosis in HIV infected persons Phase: Phase III trial Population: 650 HIV positive patients without tuberculosis Number of sites: Three 1. Tuberculosis Research centre, Chennai 2. Government General Hospital, Chennai 3. Read more about this study

Who is it for?
Ages 15 to 60 years
Conditions the study is for
Human Immunodeficiency Virus, Tuberculosis
What is being tested?
Isoniazid with Ethambutol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
683 participants
Where
1 siteIndia
Study dates
Feb 2001to Jun 2011
Phase
Phase 3
Are there results?
None posted in the registry

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 15 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age > 15 years
  • HIV positivity (on 2 different ELISA tests on the same blood sample)
  • Living in Chennai or Madurai within a defined area of intake - 25 km radius.
  • Likely to remain in the same area for at least three years after start of treatment
  • The patient is judged to be cooperative and willing for fortnightly attendance for the next 3 years
  • Is agreeable for home visits
Show all 9Show fewer
  • No major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease.
  • No other medical condition that might interfere with management like diabetes, convulsions, serious cardiac disease.
  • Patients who fulfill laboratory criteria (hemoglobin > 7.0g/l,granulocyte count>11,000/l, platelet count > 1 lakh/l. serum alanine amino transferase concentration < 2.5 times the upper limit of normal and serum creatinine concentration < 1.1 mgs%, random blood sugar < 140 mgs%) will be enrolled into the study.

Who cannot join

  • Resides outside area of intake.
  • Pregnancy and lactation.
  • Patients with major psychiatric illnesses and severe depression
  • Major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease
  • Serious cardiac disease (CCF, IHD), uncontrolled diabetes mellitus, convulsions, cancer, moribund state
  • Previous antituberculosis treatment for more than 1 month
  • Patients on ART -

Trial locations and contacts

1 site in 1 country.

India1 site

  • Tuberculosis Research Centre

    Chennai, Tamil Nadu, 600 031

Other trials in India

About this study

Official title: Evaluation of Two Different Preventive Therapy Regimens for Tuberculosis in HIV Infected Persons

Title: Evaluation of efficacy of two different preventive therapy regimens for tuberculosis in HIV infected persons

Phase: Phase III trial

Read more

Population: 650 HIV positive patients without tuberculosis

Number of sites: Three

  1. Tuberculosis Research centre, Chennai
  2. Government General Hospital, Chennai
  3. Government Rajaji Hospital, Madurai

Study Duration: 36 months

Study Objectives: To compare the efficacy of two TB preventive therapy regimens in reducing the incidence of tuberculosis and mortality among HIV-infected persons

Study Design:

The study will be a two-armed prospective randomized clinical trial among HIV- positive patients without active tuberculosis. Enrolled patients will be assigned to one of the two unsupervised self-administered treatment regimens i.e. EH for 6 months or INH alone for 3 years. At the end of a 3-year follow-up, incidence of TB and overall mortality will be compared in each group.

Study Endpoints:The primary end point of the study will be development of tuberculosis and the secondary endpoints will include adverse drug reactions and mortality rate.

Read the detailed description

Study population and enrollment:

All HIV positive patients seeking care at one of the study centers, above the age of 15 years, not suffering from a serious illness, non-pregnant, and in whom TB was ruled out using the enhanced screening process, will be enrolled in the study. The consent form for prophylaxis trial will be read to the patients in the local language and written consent will be obtained from willing patients

Randomization and Dosing:

All patients enrolled in the prevention trial will be randomized to one of the study groups using a permuted block randomization scheme of four. Stratification will be done by Mantoux reading (>5mm and ≤5mm). The group assignment list will be generated centrally before the start of trial and sequentially numbered sealed envelopes containing the study group assigned will be prepared independently. At the initiation of prophylaxis, each patient will be counseled about the importance of taking drugs regularly. Patients will be asked to return the empty packets as well as unused tablets at each monthly visit.

The treatment regimens in each study group will be as follows:

  1. Ethambutol (800 mg) and Isoniazid (300 mg) daily for six months, self-administered, collected once in fifteen days.
  2. Isoniazid (300 mg) daily for 3 years with fortnightly collection of drugs Subjects in both study groups will receive 10 mg of Pyridoxine daily during treatment.
Being tested
Isoniazid with Ethambutol
Keywords
Preventive therapy
Medical subject headings
Acquired Immunodeficiency Syndrome, Tuberculosis

What participants receive

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

  • Isoniazid with EthambutolDrug

    Isoniazid (300mg) with Ethambutol (800mg) daily for 6 months

Study groups in NCT00351702
Study groupRoleWhat they receive
IsoniazidActive comparatorIsoniazid (300mg) daily for 36 months
Receives: Drug: Isoniazid with Ethambutol
Isoniazid + EthambutolExperimentalIsoniazid (300 mg) + Ethambutol (800 mg) daily for 6 months
Receives: Drug: Isoniazid with Ethambutol

What is being measured

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

  1. Primary outcome measure is the development of tuberculosis.

    Measured: September 2008

Secondary outcomes (1)

  1. Secondary outcome measures include adverse drug reactions and mortality rate.

    Measured: September 2008

Timeline

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

  1. First posted13 Jul 2006 (estimated)
  2. Study startFeb 2001
  3. Primary completionSep 2008
  4. Study completionJun 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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
683 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00351702
Sponsor's protocol ID
trc20B
Status last verified
May 2024
First submitted
12 Jul 2006
Last updated
22 May 2024
Results posted
No
Data monitoring committee
No

Publications

  • Bucher HC, Griffith LE, Guyatt GH, Sudre P, Naef M, Sendi P, Battegay M. Isoniazid prophylaxis for tuberculosis in HIV infection: a meta-analysis of randomized controlled trials. AIDS. 1999 Mar 11;13(4):501-7. doi: 10.1097/00002030-199903110-00009.

    PubMed 10197379

  • Wilkinson D, Squire SB, Garner P. Effect of preventive treatment for tuberculosis in adults infected with HIV: systematic review of randomised placebo controlled trials. BMJ. 1998 Sep 5;317(7159):625-9. doi: 10.1136/bmj.317.7159.625.

    PubMed 9727988

  • Hawken MP, Meme HK, Elliott LC, Chakaya JM, Morris JS, Githui WA, Juma ES, Odhiambo JA, Thiong'o LN, Kimari JN, Ngugi EN, Bwayo JJ, Gilks CF, Plummer FA, Porter JD, Nunn PP, McAdam KP. Isoniazid preventive therapy for tuberculosis in HIV-1-infected adults: results of a randomized controlled trial. AIDS. 1997 Jun;11(7):875-82. doi: 10.1097/00002030-199707000-00006.

    PubMed 9189212

  • Whalen CC, Johnson JL, Okwera A, Hom DL, Huebner R, Mugyenyi P, Mugerwa RD, Ellner JJ. A trial of three regimens to prevent tuberculosis in Ugandan adults infected with the human immunodeficiency virus. Uganda-Case Western Reserve University Research Collaboration. N Engl J Med. 1997 Sep 18;337(12):801-8. doi: 10.1056/NEJM199709183371201.

    PubMed 9295239

  • Gordin F, Chaisson RE, Matts JP, Miller C, de Lourdes Garcia M, Hafner R, Valdespino JL, Coberly J, Schechter M, Klukowicz AJ, Barry MA, O'Brien RJ. Rifampin and pyrazinamide vs isoniazid for prevention of tuberculosis in HIV-infected persons: an international randomized trial. Terry Beirn Community Programs for Clinical Research on AIDS, the Adult AIDS Clinical Trials Group, the Pan American Health Organization, and the Centers for Disease Control and Prevention Study Group. JAMA. 2000 Mar 15;283(11):1445-50. doi: 10.1001/jama.283.11.1445.

    PubMed 10732934

  • Swaminathan S, Menon PA, Gopalan N, Perumal V, Santhanakrishnan RK, Ramachandran R, Chinnaiyan P, Iliayas S, Chandrasekaran P, Navaneethapandian PD, Elangovan T, Pho MT, Wares F, Paranji Ramaiyengar N. Efficacy of a six-month versus a 36-month regimen for prevention of tuberculosis in HIV-infected persons in India: a randomized clinical trial. PLoS One. 2012;7(12):e47400. doi: 10.1371/journal.pone.0047400. Epub 2012 Dec 14.

    PubMed 23251327

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Isoniazid with Ethambutol in people with Human Immunodeficiency Virus and Tuberculosis, run by Tuberculosis Research Centre, India at 1 site in India.

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 9 inclusion and 7 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 22 May 2024. 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 India. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Primary outcome measure is the development of tuberculosis. (time frame: September 2008). 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 NCT00351702, which also lists 6 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 22 May 2024.

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