Relationship Between HIV-1 Subtype and ARV Response - Full Text View

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

This study is currently recruiting participants.

Verified by University of Wisconsin, Madison, February 2009

First Received: December 26, 2007 Last Updated: February 5, 2009 History of Changes

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00585793

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:	Cohort, 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: AIDS

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

Biospecimen Description:

Plasma

Estimated Enrollment:	300
Study Start Date:	February 2007
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	July 2011 (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

Contacts

Contact: Frank M Graziano, MD/PhD

608-263-6186

fmg@medicine.wisc.edu

Locations

Uganda
	Recruiting
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:	U Wisconsin Hospital and Clinics ( Frank M Graziano )
Study ID Numbers:	H-2006-0206
Study First Received:	December 26, 2007
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00585793 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

HIV/AIDS

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on September 10, 2009