Obesity in HIV After Antiretroviral Therapy

Changes in Overweight/Obesity Status, hsCRP, and D-dimer in HIV-infected Patients After 12 Months of Initial Antiretroviral Treatment

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01461876

Enrollment

200

Registered

2011-10-28

Start date

2009-11-30

Completion date

2014-05-31

Last updated

2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS, HIV, Obesity

Brief 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

DRUGantiretroviral therapy

Standard of care antiretroviral therapy

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Inclusion Criteria for HIV-infected cohort: 1. Treatment-naive at study entry; 2. Subjects will need to remain on ART for 12 months as initiated with substitution allowed for toxicity management within the same class of drug; 3. Subjects within this group that remain on ART for an additional 12 months (total 24 months) as initiated with substitution allowed for toxicity management within the same class of drug will continue to be followed longitudinally for the 24 month period; 4. Availability of repository samples. Inclusion Criteria for Control Cohort: Followed in the Duke Primary Care Clinics during the years of inclusion with available data on weight, race and gender.

Design outcomes

Primary

Measure	Time frame
Change in BMI from baseline after 12 months of initial antiretroviral therapy	12 months

Secondary

Measure	Time frame
Change in the inflammatory marker, high-sensitivity C-reactive protein, from baseline after 12 months of antiretroviral therapy	12 Months
Change in the prothrombotic marker, D-dimer, from baseline after 12 months of initial antiretroviral therapy	12 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026