Obesity in HIV After Antiretroviral Therapy

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.