Status:
COMPLETED
Directly Observed Therapy for HIV Infected Adolescents
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pediatric AIDS Clinical Trials Group
Conditions:
HIV Infections
Eligibility:
All Genders
16-25 years
Phase:
NA
Brief Summary
Adherence to a doctor-prescribed anti-HIV drug regimen is crucial in the management of HIV infection. In previous studies with tuberculosis patients, directly observed therapy (DOT), a strategy in whi...
Detailed Description
For HIV infected people, control of HIV infection is best achieved by adhering to the highly active antiretroviral therapy (HAART) regimen prescribed by their doctors. Poor adherence to a HAART regime...
Eligibility Criteria
Inclusion
- Infected with HIV after age 12
- Initiating, continuing, changing, or reinitiating a daily or twice-daily HAART regimen AND have demonstrated adherence problems (less than 85% of prescribed doses taken, as clinically disclosed, on 2 consecutive occasions at least 1 month apart). More information on this criterion can be found in the protocol.
- Able and willing to swallow medication
- Have access to HAART
- Parent or guardian willing to provide informed consent, if applicable
- Willing to use acceptable forms of contraception
Exclusion
- Clinically significant diseases other than HIV infection or clinically significant findings during screening or physical examination that, in the opinion of the investigator, would require much closer follow-up and frequent monitoring than would be generally done for other HIV infected patients of comparable age
- HAART regimens that include medications taken more often than twice-daily
- Investigational agents (HAART or other medications) administered as part of other clinical trials
- Pregnant or breastfeeding
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00259389
Start Date
April 1 2006
End Date
September 1 2007
Last Update
September 18 2012
Active Locations (6)
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1
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Los Angeles County Medical Center/USC
Los Angeles, California, United States, 90033
3
UCSD Mother, Child & Adolescent HIV Program
San Diego, California, United States, 92103
4
Childrens Hospital of Michigan
Detroit, Michigan, United States, 48201