Obesity in HIV After Antiretroviral Therapy

NCT01461876 | Completed

• 1 other identifier: Pro00020911
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (2)

• Change in the inflammatory marker, high-sensitivity C-reactive protein, from baseline after 12 months of antiretroviral therapy

  12 Months

• Change in the prothrombotic marker, D-dimer, from baseline after 12 months of initial antiretroviral therapy

  12 Months

Study Arms (2)

HIV-infected cohort

Drug: antiretroviral therapy

HIV-uninfected control group

Interventions

antiretroviral therapy DRUG

Standard of care antiretroviral therapy

HIV-infected cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Duke University: lead
• Janssen, LP: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

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.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Obesity

Interventions

Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Officials

• Wanda Lakey, MD, MHS

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 28, 2011
• Study Start: November 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 14, 2015

Record last verified: 2014-05

Locations

US (1)