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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


  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 eligible participants who entered the study were included in analyses. One participant on Arm A did not meet entry eligibility criteria; was taken off study after the entry visit, and is therefore excluded from all 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 
Overall Participants Analyzed 
[Units: Participants]
 15   17   32 
Age 
[Units: Participants]
     
<=18 years   7   11   18 
Between 18 and 65 years   8   6   14 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   11   10   21 
Male   4   7   11 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   6   8   14 
Not Hispanic or Latino   8   9   17 
Unknown or Not Reported   1   0   1 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   2   3   5 
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   1   4   5 
Thailand   3   3   6 
Screening CD4 count 
[Units: Cells/mm3]
Mean (Standard Deviation)
 509  (176)   511  (277)   510  (232) 
HIV-1 RNA viral load 
[Units: Log10 copies/mL]
Mean (Standard Deviation)
 4.0  (1.0)   3.8  (0.7)   3.9  (0.9) 


  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