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:
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01338025
First received: April 16, 2011
Last updated: April 24, 2014
Last verified: April 2014
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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who entered the study were included in analyses.

Reporting Groups
  Description
Arm A, Non-suppressive HAART Regimen

In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen as prescribed by their primary provider.

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

Arm B, 3TC or FTC Monotherapy

In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).

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

Total Total of all reporting groups

Baseline Measures
    Arm A, Non-suppressive HAART Regimen     Arm B, 3TC or FTC Monotherapy     Total  
Number of Participants  
[units: participants]
  16     17     33  
Age  
[units: participants]
     
<=18 years     10     11     21  
Between 18 and 65 years     6     6     12  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     12     10     22  
Male     4     7     11  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     6     8     14  
Not Hispanic or Latino     9     9     18  
Unknown or Not Reported     1     0     1  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     3     3     6  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     9     8     17  
White     4     6     10  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     9     9     18  
Argentina     2     1     3  
Brazil     2     4     6  
Thailand     3     3     6  
Screening CD4 count  
[units: cells/mm3]
Median ( Inter-Quartile Range )
  490  
  ( 377 to 615 )  
  461  
  ( 384 to 683 )  
  472  
  ( 384 to 651 )  
HIV-1 RNA viral load  
[units: log10┬ácopies/mL]
Median ( Inter-Quartile Range )
  4.1  
  ( 3.3 to 4.8 )  
  4.0  
  ( 3.2 to 4.1 )  
  4.0  
  ( 3.2 to 4.5 )  



  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 ]
Results not yet posted.   Anticipated Posting Date:   12/2014   Safety Issue:   No

3.  Secondary:   Change in HIV-1 RNA Levels   [ Time Frame: 28 Weeks ]
Results not yet posted.   Anticipated Posting Date:   12/2014   Safety Issue:   No

4.  Secondary:   Adherence as Measured by 3-day Recall   [ Time Frame: 28 Weeks ]
Results not yet posted.   Anticipated Posting Date:   12/2014   Safety Issue:   No


  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: Clinictrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
phone: (617) 432-2829
e-mail: CBAR.ClinicalTrials.Gov@sdac.harvard.edu


No publications provided


Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01338025     History of Changes
Other Study ID Numbers: IMPAACT P1094, U01AI068632
Study First Received: April 16, 2011
Results First Received: April 24, 2014
Last Updated: April 24, 2014
Health Authority: United States: Federal Government