- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01461876
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
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
Description
Inclusion Criteria:
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;
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HIV-infected cohort
|
Standard of care antiretroviral therapy
|
HIV-uninfected control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in BMI from baseline after 12 months of initial antiretroviral therapy
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the inflammatory marker, high-sensitivity C-reactive protein, from baseline after 12 months of antiretroviral therapy
Time Frame: 12 Months
|
12 Months
|
Change in the prothrombotic marker, D-dimer, from baseline after 12 months of initial antiretroviral therapy
Time Frame: 12 Months
|
12 Months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wanda Lakey, MD, MHS, Duke University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00020911
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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