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

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

Study Description
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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

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Study Design
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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

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


Outcome Measures
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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

Eligibility Criteria
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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
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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
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov 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:
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