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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585793
First received: December 26, 2007
Last updated: September 29, 2015
Last verified: September 2015
  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:


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   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: 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: September 29, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 22, 2016