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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585793
First Posted: January 3, 2008
Last Update Posted: October 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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 ]

Secondary Outcome Measures:
  • Comparison of NNRTI/NRTI combinations to Kaletra/NRTI combinations in Ugandan Children [ Time Frame: 3 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: December 26, 2007
First Posted: January 3, 2008
Last Update Posted: October 1, 2015
Last Verified: September 2015

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


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