IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Relationship Between HIV-1 Subtype and ARV Response (RELATES)
This study has been completed.
Sponsor:
University of Wisconsin, Madison
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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| 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
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
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 |
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 June 23, 2017