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Obesity in HIV After Antiretroviral Therapy

NCT01461876 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2015-10-14

No results posted yet for this study

Summary

This is a retrospective longitudinal study that evaluates the prevalence and incidence of overweight/obesity within an HIV-infected population before and after 12 and 24 months of a stable antiretroviral therapy (ART). The study group will be compared to the weight of a healthy, matched population that is not infected with HIV. The primary hypothesis states that the proportion of HIV-infected persons newly classified as overweight/obese will increase by ≥20% after 12 months of initial ART, and this incidence will be greater than that of a matched HIV-uninfected control population. The effect of immune function variables, such as CD4, HIV viral load, and ART regimen on weight will be analyzed. In addition, the study will analyze the effect of weight and immune function markers on the inflammatory markers, high sensitivity C-reactive protein (hsCRP) and D-dimer. An HIV samples repository will be used for specimens to be assayed for hsCRP and D-dimer.

Conditions

Interventions

DRUG

antiretroviral therapy

Standard of care antiretroviral therapy

Sponsors & Collaborators

Principal Investigators

  • Wanda Lakey, MD, MHS · Duke University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01461876 on ClinicalTrials.gov