TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children During Treatment of Latent TB Infection

NCT00164450 | Completed Results DMC

• 1 other identifier: CDC-NCHHSTP-4679
• Study Type: interventional
• Target: 158
• Locations: 4 countries
• Sites: 24

Brief Summary

Compared to adults, children appear to require higher weight-based doses of rifapentine to acheive comparable drug levels. TBTC Study 26, a study of the effectiveness and tolerability of weekly rifapentine/isoniazid for three months versus daily isoniazid for nine months for the treatment of latent tuberculosis infection, has been amended to include children ages 2-11 based on an initial single-dose study and pharmacokinetic modeling. Study 26PK evaluates the adequacy of the doses chosen for young children enrolled in Study 26 with a single blood draw, 24 hours after the third or subsequent weekly Study 26 dose of rifapentine and isoniazid. An adult control is enrolled for each child enrolled.

Conditions

Tuberculosis

Keywords

tuberculosis; TB; pharmacokinetics; children

Outcome Measures

Primary Outcomes (2)

• Rifapentine Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity, AUC0-inf

  Rifapentine exposure was estimated in children and adults receiving once-weekly rifapentine plus isoniazid. A sparse sampling design used a plasma sample collected 24 hours after administration of study drugs.

  24 hours after study-drug administration; AUC0-inf estimated using a nonlinear mixed-effects pharmacokinetic model incorporating the 24-hour rifapentine concentration, C24.

• Correlation Between Rifapentine C24 and AUC0-inf

  Value represents the coefficient of determination (R-squared) for the relationship between rifapentine C24 and AUC0-inf.

  24 hours after study-drug administration

Secondary Outcomes (1)

• Rifapentine AUC0-inf by Tablet Administration Method in Children

  24 hours after study-drug administration

Study Arms (2)

Daily Isoniazid for 9 months

ACTIVE COMPARATOR

Participants received isoniazid daily for 9 months for treatment of latent tuberculosis infection.

Drug: Isoniazid

weekly Rifapentine plus Isoniazid for 12 weeks

EXPERIMENTAL

Participants received once-weekly rifapentine plus isoniazid for 12 weeks under direct observation for treatment of latent tuberculosis infection.

Drug: Rifapentine

Interventions

Isoniazid DRUG

Isoniazid daily, oral, nine months

Also known as: INH

Daily Isoniazid for 9 months

Rifapentine DRUG

Rifapentine plus Isoniazid taken orally, weekly, by direct observation for 12 weeks

Also known as: Priftin

weekly Rifapentine plus Isoniazid for 12 weeks

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled in TBTC Study 26 randomized to treatment with once weekly isoniazid and rifapentine:
• Child between the ages of 2 to less than 12 years for whom informed consent by a guardian and of assent (if applicable) have been obtained.
• Adult greater than age 18 for whom informed consent has been obtained.
• Willingness to undergo a blood phlebotomy 24 hours following dosing of isoniazid and rifapentine after receiving at least three once-weekly doses of rifapentine plus isoniazid.
• If as a result of a contact investigation, both a parent and child are enrolled in Study 26, both may be co-enrolled into the pharmacokinetic substudy with the adult serving as the control for the child. Preference will be given to a biologic parent of the same gender. If no eligible biologic parent is available for study, the next adult of the same gender and at the same TBTC site, who is substudy eligible, will serve as the adult control.

You may not qualify if:

• None

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• US Department of Veterans Affairs: collaborator

Study Sites (24)

Central Arkansas Veterans Health System

Little Rock, Arkansas, 72205, United States

Location

University of Southern California Medical Center

Los Angeles, California, 90033, United States

Location

University of California at San Diego

San Diego, California, 92103, United States

Location

University of California, San Francisco

San Francisco, California, 94110, United States

Location

Denver Public Health Department

Denver, Colorado, 80204, United States

Location

Washington DC Veterans Administration Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30303, United States

Location

Northwestern University School of Medicine

Chicago, Illinois, 21231, United States

Location

Hines Veterans Administration Medical Center

Hines, Illinois, 60141, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21231, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

New Jersey School of Medicine

Newark, New Jersey, 07103, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Veterans Administration Tennessee Valley Health Care System

Nashville, Tennessee, 37232, United States

Location

University of North Texas Health Science Center

Fort Worth, Texas, 76104, United States

Location

Houston Veterans Administration Medical Center

Houston, Texas, 77030, United States

Location

Audie L. Murphy VA Hospital

San Antonio, Texas, 78284, United States

Location

Seattle-King County Health Department

Seattle, Washington, 98104, United States

Location

Hopital Universitario Clementino Fraga Filho

Rio de Janeiro, 2194.590, Brazil

Location

University of British Columbia

Vancouver, British Columbia, V5Z 4R4, Canada

Location

University of Manitoba

Winnepeg, Manitoba, R3A 1R8, Canada

Location

Montreal Chest Institute

Montreal, Quebec, H2X 2P4, Canada

Location

Agencia de Salut Publica

Barcelona, 080023, Spain

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Isoniazid; rifapentine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Pharmacokinetic analysis used sparse sampling with rifapentine concentration measured 24 hours post-dose and AUC0-inf estimated using a nonlinear mixed-effects model. Child/adult comparisons were not randomized. Some pediatric participants received crushed rifapentine tablets rather than whole tablets, which may have affected pharmacokinetic estimates.

Results Point of Contact

• Title: William R. Mac Kenzie, MD
• Organization: Centers for Disease Control and Prevention (CDC), NCHHSTP/DTBE

wrm0@cdc.gov

404 639-8123

Study Officials

• Marc Weiner, MD

  VAMC and University of Texas Health Science Center San Antonio

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 14, 2005
• Study Start: September 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: July 7, 2026
• Results First Posted: July 7, 2026

Record last verified: 2026-06

Locations

BR (1); ES (1); CA (3); US (19)