Trial record 9 of 1235 for:    "Observational" [STUDY-TYPES] AND HIV [CONDITION]

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

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. Identifier: NCT00585793
Recruitment Status : Completed
First Posted : January 3, 2008
Last Update Posted : October 1, 2015
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
Does subtype of HIV-1 affect the response of ARVs given to Ugandan children

Condition or disease Intervention/treatment
HIV Infections Drug: NRTI/NNRTI/ Kaletra

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Relationship Between HIV-1 Subtype and Antiretroviral (ARV) Response in Ugandan Children
Study Start Date : July 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lopinavir

Group/Cohort Intervention/treatment
PEPFAR 1 Drug: NRTI/NNRTI/ Kaletra
Fixed dose and cild formulation Kaletra

Primary Outcome Measures :
  1. HIV-1 subtype affects response to ARVs [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. 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

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

Inclusion Criteria:

  • PEPFAR eligible

Exclusion Criteria:

  • OI/sfaety lab abnomalities

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 identifier (NCT number): NCT00585793

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

Responsible Party: University of Wisconsin, Madison Identifier: NCT00585793     History of Changes
Other Study ID Numbers: H-2006-0206
First Posted: January 3, 2008    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015

Keywords provided by University of Wisconsin, Madison:

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
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