Obesity in HIV After Antiretroviral Therapy

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461876
• Other study ID #: Pro00020911
• Status: Completed
• Phase: N/A
• First received: October 10, 2011
• Last updated: October 11, 2015
• Start date: November 2009
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

Exclusion Criteria for HIV-infected cohort:

1. Pregnancy during period of observation or within 6 months of study entry;

2. Malignancy (other than squamous or basal cell carcinomas of the skin);

3. Newly diagnosed thyroid disorder within 6 months of study entry;

4. Use of megace or marinol;

5. Long-term use of glucocorticoids (greater than 1 month of prednisone 5mg or higher or an equivalent dose of another glucocorticoid);

6. Use of androgenic steroids;

7. History of diabetes or use of glucose-lowering agents;

8. Use of the following psychiatric or anticonvulsant agents- thioridazine, olanzapine (zyprexa), clozapine (clozaril), quetiapine (seroquel), risperidone (risperdal), lithium, remeron, paxil, valproate, carbamazepine, gabapentin;

9. Concurrent treatment for hepatitis C infection;

10. Diagnosis of a new opportunistic infection (OI) as defined by the CDC during the 1st 12 months of ART.22 OIs include the following: PCP, toxoplasmosis, MAC, histoplasmosis, candidiasis, cryptococcus, coccidiodes, CMV, cryptosporidium, microsporidiosis, tuberculosis, bartonellosis, herpes simplex virus, HHV-8, human papillomavirus;

11. Diagnosis of congestive heart failure and receiving diuretic therapy;

12. End stage renal disease.

Exclusion Criteria for Control Cohort:

1. Pregnancy during period of observation or within 6 months of study entry;

2. Malignancy (other than squamous or basal cell carcinomas of the skin);

3. Newly diagnosed thyroid disorder within 6 months of study entry;

4. Long-term use of glucocorticoids (greater than 1 month of prednisone 5mg or higher or an equivalent dose of another glucocorticoid);

5. Use of androgenic steroids;

6. History of diabetes or use of glucose-lowering agents;

7. Use of the following psychiatric or anticonvulsant agents- thioridazine, olanzapine (zyprexa), clozapine (clozaril), quetiapine (seroquel), risperidone (risperdal), lithium, remeron, paxil, valproate, carbamazepine, gabapentin;

8. Treatment for hepatitis C infection during observation period;

9. Diagnosis of congestive heart failure and receiving diuretic therapy;

10. End stage renal disease.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• AIDS
• HIV
• Obesity

Intervention

Drug:
• antiretroviral therapy
Standard of care antiretroviral therapy

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Janssen, LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BMI from baseline after 12 months of initial antiretroviral therapy		12 months	No
Secondary	Change in the inflammatory marker, high-sensitivity C-reactive protein, from baseline after 12 months of antiretroviral therapy		12 Months	No
Secondary	Change in the prothrombotic marker, D-dimer, from baseline after 12 months of initial antiretroviral therapy		12 Months	No