Short Course Intermittent Regimens for the Treatment of HIV-Associated Tuberculosis

NCT00376012 | Unknown Phase 3

• 1 other identifier: trc20A
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Title: Randomized clinical trial to assess the efficacy of short course intermittent regimens for the treatment of HIV-associated tuberculosis Phase: Phase III trial Population: 300 HIV positive patients with tuberculosis. Number of Sites:Four

1. 1.Tuberculosis Research Centre, Chennai
2. 2.Government General Hospital, Chennai
3. 3.Government Hospital of Thoracic Medicine, Tambaram
4. 4.Government Rajaji Hospital, Madurai

Conditions

Tuberculosis; Human Immunodeficiency Virus Infections

Keywords

Chemotherapy for TB in HIV infection

Outcome Measures

Primary Outcomes (1)

• Primary outcome measures are TB cure and relapse rates

  2 years

Secondary Outcomes (1)

• Secondary Outcome measure is mortality rates.

  2 years

Study Arms (2)

1

ACTIVE COMPARATOR

2EHRZ3/4RH3

Drug: Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide)

2

EXPERIMENTAL

2EHRZ3/7RH3

Drug: Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide)

Interventions

Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide) DRUG

Arm 1 is a standard six-month intermittent regimen consisting of Ethambutol, Isoniazid, Rifampicin and Pyrazinamide given thrice weekly for 2 months followed by Rifampicin and Isoniazid given thrice-weekly for 4 months.

1

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 thrice-weekly attendance for the first 2/3 months and once-weekly thereafter for the next 4 to 7 months
• Is agreeable for home visits
• 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 =\>70 g/L, granulocyte count \>1.1 X 109/L, platelet count \> 100X 109/L, serum alanine amino transferase concentration \<2.5 times the upper limit of normal, serum creatinine concentration \<1.1mg%, random blood sugar \< 140 mg/dl) will be enrolled in to the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Tuberculosis Research Centre, India: lead

Study Sites (1)

Tuberculosis Research Centre

Chennai, Tamil Nadu, 600 031, India

Location

Related Publications (7)

• Chaisson RE, Clermont HC, Holt EA, Cantave M, Johnson MP, Atkinson J, Davis H, Boulos R, Quinn TC, Halsey NA. Six-month supervised intermittent tuberculosis therapy in Haitian patients with and without HIV infection. Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):1034-8. doi: 10.1164/ajrccm.154.4.8887603.

  PMID: 8887603 BACKGROUND

• El-Sadr WM, Perlman DC, Denning E, Matts JP, Cohn DL. A review of efficacy studies of 6-month short-course therapy for tuberculosis among patients infected with human immunodeficiency virus: differences in study outcomes. Clin Infect Dis. 2001 Feb 15;32(4):623-32. doi: 10.1086/318706. Epub 2001 Feb 9.

  PMID: 11181127 BACKGROUND

• Perriens JH, St Louis ME, Mukadi YB, Brown C, Prignot J, Pouthier F, Portaels F, Willame JC, Mandala JK, Kaboto M, et al. Pulmonary tuberculosis in HIV-infected patients in Zaire. A controlled trial of treatment for either 6 or 12 months. N Engl J Med. 1995 Mar 23;332(12):779-84. doi: 10.1056/NEJM199503233321204.

  PMID: 7862181 BACKGROUND

• Kassim S, Sassan-Morokro M, Ackah A, Abouya LY, Digbeu H, Yesso G, Coulibaly IM, Coulibaly D, Whitaker PJ, Doorly R, et al. Two-year follow-up of persons with HIV-1- and HIV-2-associated pulmonary tuberculosis treated with short-course chemotherapy in West Africa. AIDS. 1995 Oct;9(10):1185-91. doi: 10.1097/00002030-199510000-00011.

  PMID: 8519456 BACKGROUND

• Alwood K, Keruly J, Moore-Rice K, Stanton DL, Chaulk CP, Chaisson RE. Effectiveness of supervised, intermittent therapy for tuberculosis in HIV-infected patients. AIDS. 1994 Aug;8(8):1103-8. doi: 10.1097/00002030-199408000-00010.

  PMID: 7986406 BACKGROUND

• el-Sadr WM, Perlman DC, Matts JP, Nelson ET, Cohn DL, Salomon N, Olibrice M, Medard F, Chirgwin KD, Mildvan D, Jones BE, Telzak EE, Klein O, Heifets L, Hafner R. Evaluation of an intensive intermittent-induction regimen and duration of short-course treatment for human immunodeficiency virus-related pulmonary tuberculosis. Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) and the AIDS Clinical Trials Group (ACTG). Clin Infect Dis. 1998 May;26(5):1148-58. doi: 10.1086/520275.

  PMID: 9597244 BACKGROUND

• Swaminathan S, Narendran G, Venkatesan P, Iliayas S, Santhanakrishnan R, Menon PA, Padmapriyadarsini C, Ramachandran R, Chinnaiyan P, Suhadev M, Sakthivel R, Narayanan PR. Efficacy of a 6-month versus 9-month intermittent treatment regimen in HIV-infected patients with tuberculosis: a randomized clinical trial. Am J Respir Crit Care Med. 2010 Apr 1;181(7):743-51. doi: 10.1164/rccm.200903-0439OC. Epub 2009 Dec 3.

  PMID: 19965813 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Ethambutol; Isoniazid; Rifampin; Pyrazinamide

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Hydrazines; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Pyrazines

Study Officials

• Soumya Swaminathan, MD MNAMS

  Tuberculosis Research Centre, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 13, 2006
• First Posted: September 14, 2006
• Study Start: February 1, 2001
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2008
• Last Updated: June 11, 2008

Record last verified: 2008-05

Locations

IN (1)