Obesity in HIV After Antiretroviral Therapy
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ClinicalTrials.gov Identifier: NCT01461876 |
Recruitment Status :
Completed
First Posted : October 28, 2011
Last Update Posted : October 14, 2015
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Condition or disease | Intervention/treatment |
---|---|
HIV AIDS Obesity | Drug: antiretroviral therapy |
Study Type : | Observational |
Actual Enrollment : | 200 participants |
Observational Model: | Case-Control |
Time Perspective: | Retrospective |
Official Title: | Changes in Overweight/Obesity Status, hsCRP, and D-dimer in HIV-infected Patients After 12 Months of Initial Antiretroviral Treatment |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | May 2014 |
Group/Cohort | Intervention/treatment |
---|---|
HIV-infected cohort |
Drug: antiretroviral therapy
Standard of care antiretroviral therapy |
HIV-uninfected control group |
- Change in BMI from baseline after 12 months of initial antiretroviral therapy [ Time Frame: 12 months ]
- Change in the inflammatory marker, high-sensitivity C-reactive protein, from baseline after 12 months of antiretroviral therapy [ Time Frame: 12 Months ]
- Change in the prothrombotic marker, D-dimer, from baseline after 12 months of initial antiretroviral therapy [ Time Frame: 12 Months ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Adult subjects (≥ 18 years of age) infected with HIV-1 treated in the Infectious Disease Clinic at Duke University Medical Center between 3/1/98 to 3/1/08 who meet eligibility criteria.
Adult subjects (≥ 18 years of age), followed in primary care clinics within the Duke Health System between 3/1/98 to 3/1/08, who meet eligibility criteria. Control subjects must have data for weight 12 months after baseline visit.
Inclusion Criteria:
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Inclusion Criteria for HIV-infected cohort:
- Treatment-naive at study entry;
- Subjects will need to remain on ART for 12 months as initiated with substitution allowed for toxicity management within the same class of drug;
- 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;
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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:
- Pregnancy during period of observation or within 6 months of study entry;
- Malignancy (other than squamous or basal cell carcinomas of the skin);
- Newly diagnosed thyroid disorder within 6 months of study entry;
- Use of megace or marinol;
- Long-term use of glucocorticoids (greater than 1 month of prednisone 5mg or higher or an equivalent dose of another glucocorticoid);
- Use of androgenic steroids;
- History of diabetes or use of glucose-lowering agents;
- Use of the following psychiatric or anticonvulsant agents- thioridazine, olanzapine (zyprexa), clozapine (clozaril), quetiapine (seroquel), risperidone (risperdal), lithium, remeron, paxil, valproate, carbamazepine, gabapentin;
- Concurrent treatment for hepatitis C infection;
- 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;
- Diagnosis of congestive heart failure and receiving diuretic therapy;
- End stage renal disease.
Exclusion Criteria for Control Cohort:
- Pregnancy during period of observation or within 6 months of study entry;
- Malignancy (other than squamous or basal cell carcinomas of the skin);
- Newly diagnosed thyroid disorder within 6 months of study entry;
- Long-term use of glucocorticoids (greater than 1 month of prednisone 5mg or higher or an equivalent dose of another glucocorticoid);
- Use of androgenic steroids;
- History of diabetes or use of glucose-lowering agents;
- Use of the following psychiatric or anticonvulsant agents- thioridazine, olanzapine (zyprexa), clozapine (clozaril), quetiapine (seroquel), risperidone (risperdal), lithium, remeron, paxil, valproate, carbamazepine, gabapentin;
- Treatment for hepatitis C infection during observation period;
- Diagnosis of congestive heart failure and receiving diuretic therapy;
- End stage renal disease.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461876
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Wanda Lakey, MD, MHS | Duke University |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT01461876 |
Other Study ID Numbers: |
Pro00020911 |
First Posted: | October 28, 2011 Key Record Dates |
Last Update Posted: | October 14, 2015 |
Last Verified: | May 2014 |
Obesity Overnutrition Nutrition Disorders Overweight |
Body Weight Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |