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

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 (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 September 30, 2016

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