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Helping HIV Infected Patients in South Africa Adhere to Drug Regimens

This study has been terminated.
(DSMB stopped trial for futility)
Sponsor:
Collaborator:
University of Cape Town
Information provided by (Responsible Party):
Dr. Richard Chaisson, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00076804
First received: February 3, 2004
Last updated: March 9, 2015
Last verified: March 2015
Results First Received: June 1, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Behavioral: Directly Observed Therapy

  Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Peer Supporter Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
Self Administration Self administration of ARVs
Total Total of all reporting groups

Baseline Measures
   Peer Supporter   Self Administration   Total 
Overall Participants Analyzed 
[Units: Participants]
 137   137   274 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   134   136   270 
>=65 years   3   1   4 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.7  (9.7)   36.7  (9.2)   36.2  (9.1) 
Gender 
[Units: Participants]
     
Female   79   79   158 
Male   58   58   116 
Region of Enrollment 
[Units: Participants]
     
South Africa   137   137   274 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment   [ Time Frame: at 12 and 24 months of treatment ]

2.  Primary:   Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment   [ Time Frame: 24 months ]

3.  Primary:   Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm   [ Time Frame: 12 months ]

4.  Primary:   Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm   [ Time Frame: 24 months ]


  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
Intervention was stopped at 12 months, transition phase did not ensure that participants developed a set of adherence strategies to replace DOT-ART. Low incidence of AIDS-defining illness and death limit our ability to make final conclusions


  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: Richard E. Chaisson
Organization: Johns Hopkins University Center for TB Research
phone: 4109551755
e-mail: rchaiss@jhmi.edu


Publications of Results:

Responsible Party: Dr. Richard Chaisson, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00076804     History of Changes
Other Study ID Numbers: 1R01AI055359-01A1 ( U.S. NIH Grant/Contract )
Study First Received: February 3, 2004
Results First Received: June 1, 2010
Last Updated: March 9, 2015