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NCT01461876 · ClinicalTrials.gov registry record

Obesity in HIV After Antiretroviral Therapy

A clinical trial, sponsored by Duke University.

Completed
Registry status
200
Enrollment target

NCT01461876: Completed study, sponsored by Duke University.

NCT01461876 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01461876 has completed, sponsored by Duke University.

COMPLETED
Registry status
200 participants
Enrollment target

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.

Interventions

  • DRUG antiretroviral therapy

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2009-11
Est. Completion 2014-05
Duke University

1,725 total trials

What the finished NCT01461876 record still lists

NCT01461876 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which antiretroviral therapy is the first listed.

NCT01461876 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01461876 about?

NCT01461876 is a clinical study titled "Obesity in HIV After Antiretroviral Therapy". 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 t...

What is the current status of trial NCT01461876?

This trial is currently completed. The enrollment target is 200 participants. The study started on 2009-11. Estimated completion is 2014-05.

What interventions are being tested in trial NCT01461876?

The interventions under investigation include: antiretroviral therapy (DRUG).

Who is sponsoring clinical trial NCT01461876?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01461876, the US trial registry maintained by the National Library of Medicine. NCT01461876 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.