MedTrace Logo

Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Strategy

NCT01338025 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2015-11-13

Study results available
· View outcomes & findings →

Summary

The purpose of this study was to compare the use of lamivudine (3TC) or emtricitabine (FTC) alone vs. continuing a failing highly active antiretroviral therapy (HAART) regimen in HIV infected children, adolescents and young adults. The study was to see if there were changes in the HIV virus and if there were differences in immune function, viral load and medication side effects between the two groups over 28 weeks. Participants were assigned to either take 3TC or FTC alone or continue on his/her current failing HAART regimen. During the first 28 weeks of this study, if the participant was randomized to the continue HAART arm, he/she was not switched to a different or new, potentially suppressive HAART regimen, but continued on the current failing HAART regimen. However, if continuing HAART, the participant might be switched to a new regimen if their provider felt that it was clinically needed or the participant met certain study endpoints (e.g., drop in CD4, increase in viral load).

At the end of 28 weeks, the participant had the choice of remaining on the assigned study group medication(s) or starting a new HAART regimen prescribed by his/her doctor. Then, they would be followed for another 24 weeks to compare the difference in immune function, viral load and medication side effects between the different groups.

Conditions

  • HIV Disease

Interventions

DRUG

HAART regimen

The study participant continued their non-suppressive HAART regimen as prescribed by their primary provider.

DRUG

3TC or FTC monotherapy

The study participant was assigned to either 3TC or FTC monotherapy (the choice of 3TC or FTC was left to the provider.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • International Maternal Pediatric Adolescent AIDS Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Allison L. Agwu, MD, Sc.M. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States
  • Argentina
  • Brazil
  • Puerto Rico
  • Thailand

Study Locations

More Related Trials

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 NCT01338025 on ClinicalTrials.gov