Obesity in HIV After Antiretroviral Therapy

October 11, 2015 updated by: Duke University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
HIV-infected cohort
Drug: antiretroviral therapy
Standard of care antiretroviral therapy
HIV-uninfected control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Janssen, LP

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wanda Lakey, MD, MHS, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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