Relationship Between HIV-1 Subtype and ARV Response (RELATES)

This study has been completed.
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: December 26, 2007
Last updated: September 29, 2015
Last verified: September 2015

Does subtype of HIV-1 affect the response of ARVs given to Ugandan children

Condition Intervention
HIV Infections
Drug: NRTI/NNRTI/ Kaletra

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Relationship Between HIV-1 Subtype and Antiretroviral (ARV) Response in Ugandan Children

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • HIV-1 subtype affects response to ARVs [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of NNRTI/NRTI combinations to Kaletra/NRTI combinations in Ugandan Children [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma obtained from participants

Enrollment: 108
Study Start Date: July 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PEPFAR 1 Drug: NRTI/NNRTI/ Kaletra
Fixed dose and cild formulation Kaletra

  Show Detailed Description


Ages Eligible for Study:   4 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Children $ ,monthe to 16 years


Inclusion Criteria:

  • PEPFAR eligible

Exclusion Criteria:

  • OI/sfaety lab abnomalities
  Contacts and Locations
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Please refer to this study by its identifier: NCT00585793

Kampala, Uganda
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Frank M Graziano, MD/PhD UWHC
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison Identifier: NCT00585793     History of Changes
Other Study ID Numbers: H-2006-0206
Study First Received: December 26, 2007
Last Updated: September 29, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
HIV/AIDS processed this record on October 02, 2015