Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00608569
First received: January 21, 2008
Last updated: November 14, 2013
Last verified: November 2013
Results First Received: September 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: HIV Infections
Interventions: Drug: Lopinavir/ritonavir
Drug: Emtricitabine/Tenofovir disoproxil fumarate
Drug: Tenofovir disoproxil fumarate
Drug: Zidovudine
Drug: Emtricitabine

  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 across 9 study sites (2 in Peru, one each in South Africa, Haiti, Uganda, Botswana, Zimbabwe, Brazil and Zambia) in the AIDS Clinical Trials Group system between April 2009 and September 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Five hundred twenty nine subjects including participants and partners entered the study. Among the 529 subjects, 259 were participants, which included two participants with eligibility violations. Only the 257 eligible participants were included in the analyses. All participants started TDF/FTC +LPV/rtv and stratified by screening HIV-1 RNA only.

Reporting Groups
  Description
mDOT Arm Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
Non-mDOT Arm Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.

Participant Flow:   Overall Study
    mDOT Arm     Non-mDOT Arm  
STARTED     129     128  
COMPLETED     119     119  
NOT COMPLETED     10     9  
Death                 4                 3  
Lost to Follow-up                 4                 5  
Withdrawal by Subject                 1                 0  
Adverse Event                 1                 0  
Unable to adhere with study requirements                 0                 1  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Confirmed Virologic Failure at or Prior to Week 48   [ Time Frame: At or prior to Week 48 ]

2.  Secondary:   Confirmed Virologic Failure at or Prior to Week 24   [ Time Frame: At or prior to Week 24 ]

3.  Secondary:   CD4 Count at Follow-up Visits   [ Time Frame: At Weeks 4, 12, 24, 36, and 48 ]

4.  Secondary:   CD8 Count at Follow-up Visits   [ Time Frame: At week 4, 12, 24, 36, and 48 ]

5.  Secondary:   Time to First Grade 3 or 4 Lab Event   [ Time Frame: 52 weeks since randomization ]

6.  Secondary:   Time to First Grade 3 or 4 Sign or Symptom   [ Time Frame: 52 weeks since randomization ]

7.  Secondary:   Time to First Grade 3 or 4 Lab or Sign/Symptom Event   [ Time Frame: 52 weeks since randomization ]

8.  Secondary:   Adherence to Second Line HAART Regimen   [ Time Frame: At weeks 4, 8, 12, 24, 36, 48 and 52 ]


  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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