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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frank Graziano, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585793
First received: December 26, 2007
Last updated: March 9, 2012
Last verified: March 2012
History of Changes
  Purpose

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:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lopinavir
U.S. FDA Resources

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

  Eligibility

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

Criteria

Inclusion Criteria:

  • PEPFAR eligible

Exclusion Criteria:

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

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

No publications provided

Responsible Party: Frank Graziano, Professor of Medicine, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585793     History of Changes
Other Study ID Numbers: H-2006-0206
Study First Received: December 26, 2007
Last Updated: March 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
HIV/AIDS

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 21, 2013