HIVNCT01461876

Obesity in HIV After Antiretroviral Therapy

An observational study of HIV and AIDS, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV, AIDS, Obesity
What is being tested?: antiretroviral therapy
How many people: 200 participants
Where: 1 siteUnited States
Study dates: Nov 2009to May 2014
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.
Followed in the Duke Primary Care Clinics during the years of inclusion with available data on weight, race and gender.

Who cannot join

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;

Show all 22Show fewer

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.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: 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.

Conditions: HIV, AIDS, Obesity
Being tested: antiretroviral therapy
Medical subject headings: Acquired Immunodeficiency Syndrome, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

antiretroviral therapyDrug
Standard of care antiretroviral therapy

Study groups in NCT01461876
Study group	Role	What they receive
HIV-infected cohort		Not described Receives: Drug: antiretroviral therapy
HIV-uninfected control group		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in BMI from baseline after 12 months of initial antiretroviral therapy
Measured: 12 months

Secondary outcomes (2)

Change in the inflammatory marker, high-sensitivity C-reactive protein, from baseline after 12 months of antiretroviral therapy
Measured: 12 Months
Change in the prothrombotic marker, D-dimer, from baseline after 12 months of initial antiretroviral therapy
Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009May 2014

First posted28 Oct 2011 (estimated)
Study startNov 2009
Primary completionMay 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01461876
Sponsor's protocol ID: Pro00020911
Status last verified: May 2014
First submitted: 10 Oct 2011
Last updated: 14 Oct 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Changes in Overweight/Obesity Status, hsCRP, and D-dimer in HIV-infected Patients After 12 Months of Initial Antiretroviral Treatment
ClinicalTrials.gov ID: NCT01461876
Acronym / sponsor ID: Pro00020911
Conditions: HIV, AIDS, Obesity
Study type: Observational
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: Janssen, LP
Study start: Nov 2009
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 28 Oct 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
HIV-infected cohort	–	Drug: antiretroviral therapy
HIV-uninfected control group	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (5 listed)

Followed in the Duke Primary Care Clinics during the years of inclusion with available data on weight, race and gender.

Key exclusion criteria (22 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
antiretroviral therapyStandard of care antiretroviral therapy	Drug	HIV-infected cohort

Primary outcome

Change in BMI from baseline after 12 months of initial antiretroviral therapy
Time frame: 12 months

2 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wanda Lakey, MD, MHS principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV and AIDS, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in BMI from baseline after 12 months of initial antiretroviral therapy (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01461876.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.