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Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Strategy (P1094)

This study has been terminated.
(Study was halted for lack of accrual)
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01338025
First received: April 16, 2011
Last updated: October 14, 2015
Last verified: October 2015
Results First Received: April 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Disease
Interventions: Drug: HAART regimen
Drug: 3TC or FTC monotherapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 17 sites in the United States, Argentina, Brazil and Thailand. Enrollment occurred from May 10, 2011 to January 16, 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants were HIV-infected, ≥8 to <25 years of age with documentation of the M184V HIV resistance mutation, were failing their current antiretroviral regimen and were persistently non-adherent. Participants were randomized equally to the two study arms.

Reporting Groups
  Description
Arm A, Non-suppressive HAART Regimen

In Step 1, subjects were randomized to continue their non-suppressive HAART regimen.

In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinued therapy while remaining on follow-up, as decided by their provider.

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

Arm B, 3TC or FTC Monotherapy

In step 1, subjects were randomized to receive 3TC or FTC (the choice of 3TC or FTC was left to the provider.) In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.

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.)


Participant Flow:   Overall Study
    Arm A, Non-suppressive HAART Regimen   Arm B, 3TC or FTC Monotherapy
STARTED   16   17 
COMPLETED   5   6 
NOT COMPLETED   11   11 
Unexpected closure of study                10                9 
Withdrawal by Subject                0                2 
Found ineligible after starting                1                0 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Immunologic Deterioration   [ Time Frame: From entry to week 28 ]

2.  Secondary:   Change in CD4+ T Cell Count   [ Time Frame: Entry to week 28 ]

3.  Secondary:   Change in HIV-1 RNA Levels   [ Time Frame: 28 Weeks ]

4.  Secondary:   Number of Participants Non-adherent as Measured by 3-day Recall   [ Time Frame: 28 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)
phone: (919) 405-1429
e-mail: mallen@fhi360.org



Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01338025     History of Changes
Other Study ID Numbers: IMPAACT P1094
U01AI068632 ( US NIH Grant/Contract Award Number )
Study First Received: April 16, 2011
Results First Received: April 24, 2014
Last Updated: October 14, 2015
Health Authority: United States: Federal Government