Obesity in HIV After Antiretroviral Therapy

This study has been completed.
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01461876
First received: October 10, 2011
Last updated: June 4, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
HIV
AIDS
Obesity
Drug: antiretroviral therapy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in BMI from baseline after 12 months of initial antiretroviral therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the inflammatory marker, high-sensitivity C-reactive protein, from baseline after 12 months of antiretroviral therapy [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Change in the prothrombotic marker, D-dimer, from baseline after 12 months of initial antiretroviral therapy [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

These samples represent residual plasma retained after clinical testing (HIV RNA PCR) has been completed. Since the samples were obtained as part of routine clinical care, they are part of the HIV samples repository at Duke University Medical Center.


Enrollment: 200
Study Start Date: November 2009
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV-infected cohort Drug: antiretroviral therapy
Standard of care antiretroviral therapy
HIV-uninfected control group

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01461876

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Janssen, LP
Investigators
Principal Investigator: Wanda Lakey, MD, MHS Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01461876     History of Changes
Other Study ID Numbers: Pro00020911
Study First Received: October 10, 2011
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014