Tuberculosis Prevention for HIV Infected Adults

NCT00057122 | Completed Phase 3

• 2 other identifiers: 1R01AI048526-01A15R01AI048526-02
• Study Type: interventional
• Target: 1,148
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares three different tuberculosis (TB) prevention regimens against the standard regimen of 6 months of isoniazid. It is being conducted in Soweto, South Africa. People who are HIV positive and have a positive tuberculin skin test without signs of active tuberculosis may join.

Conditions

HIV Infections; Tuberculosis

Keywords

Preventive therapy

Outcome Measures

Primary Outcomes (1)

• Development of confirmed, probable, or possible active pulmonary or extrapulmonary tuberculosis (TB)

  6/2008

Secondary Outcomes (4)

• Risk of TB and death

  6/2008

• rates of adherence, adverse reactions and treatment discontinuation

  6/2008

• patterns of antibiotic resistance

  6/2008

• clinical and epidemiological factors associated with developing TB

  6/2008

Study Arms (4)

1

ACTIVE COMPARATOR

Drug: Isoniazid; Drug: Rifapentine

2

ACTIVE COMPARATOR

Drug: Isoniazid; Drug: Rifampin

3

ACTIVE COMPARATOR

Drug: Isoniazid

4

ACTIVE COMPARATOR

Drug: Isoniazid

Interventions

Isoniazid DRUG

300mg

1; 2; 3; 4

Rifapentine DRUG

Rifapentine 900 mg

1

Rifampin DRUG

Rifampin 600 mg

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infected
• Tuberculin test (PPD) positive 5 mm or greater
• Chest x-ray negative for pulmonary tuberculosis

You may not qualify if:

• Pregnant or breastfeeding

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Chris Hani Baragwanath Hospital

Soweto, South Africa

Location

Related Publications (2)

• Singh P, Moulton LH, Barnes GL, Gupta A, Msandiwa R, Chaisson RE, Martinson NA. Pregnancy in Women With HIV in a Tuberculosis Preventive Therapy Trial. J Acquir Immune Defic Syndr. 2022 Dec 1;91(4):397-402. doi: 10.1097/QAI.0000000000003078.

  PMID: 36000934 DERIVED

• Martinson NA, Barnes GL, Moulton LH, Msandiwa R, Hausler H, Ram M, McIntyre JA, Gray GE, Chaisson RE. New regimens to prevent tuberculosis in adults with HIV infection. N Engl J Med. 2011 Jul 7;365(1):11-20. doi: 10.1056/NEJMoa1005136.

  PMID: 21732833 DERIVED

MeSH Terms

Conditions

HIV Infections; Tuberculosis

Interventions

Isoniazid; rifapentine; Rifampin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; 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

Study Officials

• Richard Chaisson, MD

  Johns Hopkins Medical Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for TB Research

Study Record Dates

• First Submitted: March 27, 2003
• First Posted: March 28, 2003
• Study Start: September 1, 2002
• Primary Completion: November 1, 2008
• Study Completion: June 1, 2009
• Last Updated: October 22, 2012

Record last verified: 2012-10

Locations

ZA (1)