MedTrace Logo

Evaluation of the Effect of 3HP vs Periodic 3HP vs 6H in HIV-Positive Individuals

NCT02980016 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4027

Last updated 2019-10-30

No results posted yet for this study

Summary

This study is a parallel, two part, open label, individually randomized, pragmatic trial among HIV-positive individuals. Part A compares a single round of weekly high dose rifapentine plus isoniazid for three months (3HP) to six months of daily isoniazid (6H). Part B compares periodic 3HP (p3HP) to a single round of 3HP.

Conditions

Interventions

DRUG

rifapentine + isoniazid

Rifapentine + isoniazid Once weekly rifapentine (at a dose of 900 mg) plus isoniazid (at a dose of 900 mg), with adjustment for participants weighing ≤50 kg

DRUG

Isoniazid

Daily self-administered isoniazid (at a dose of 300 mg/daily), with adjustment for participants weighing ≤24 kg

Sponsors & Collaborators

  • Aurum Institute

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • The Aurum Institute NPC

    lead OTHER

Principal Investigators

  • Gavin Churchyard, MBBCh, PhD · Aurum Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-10-18
Completion
2019-10-18

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02980016 on ClinicalTrials.gov