Metabolic Abnormalities in HIV Infected and Uninfected Young Women

Prevalence of Morphologic and Metabolic Abnormalities in HIV Infected and Uninfected Young Women

Though anti-HIV drugs can dramatically improve the health of people with HIV, some people taking these drugs develop serious long term effects in their metabolism. These effects include problems with bones, increased levels of blood sugar and lipids, and changes in body fat distribution. The purpose of this study is to see how many young women are experiencing these problems and how severe the problems are. This kind of study is the first step in determining how best to treat these problems.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Glucose Intolerance; Hypercholesterolemia

Detailed Description

Patients on highly active antiretroviral therapy (HAART) regimens develop potentially deleterious metabolic effects, including insulin resistance, dyslipidemia, osteopenia and osteoporosis, and hyperlactatemia. Changes in body fat distribution and bone metabolism are also documented. There is considerable evidence that protease inhibitors (PI) can induce insulin resistance and increase triglyceride and cholesterol levels. It is now also clear that both metabolic changes and fat distribution abnormalities occur in PI-naive patients treated with nucleoside analogue reverse transcriptase inhibitors (NRTIs). In addition to class specific effects, there is emerging evidence that there are differences within each class of drug in the nature and magnitude of metabolic effects. This study will examine the metabolic effects of HAART in young women.

Adolescent women aged 12 through 24 years will be recruited into each of 5 treatment strata: Stratum 1 - HIV uninfected; Stratum 2 - HIV infected but never had HAART; Stratum 3 - HIV infected on NNRTI regimen for 3 or more months and less than 2 weeks of PI therapy; Stratum 4 - HIV infected on PI regimen for 3 or more months and less than 2 weeks of NNRTI therapy; and Stratum 5 - HIV infected on NRTI-only regimen for 3 or more months and less than 2 weeks of PI or NNRTI therapy. Participants in the study will have one study visit conducted over 1 or 2 days. The study visit will include survey questionnaires, DEXA scanning, anthropometric measurements, and blood tests examining lactate, glucose, and lipid metabolism.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hopsital of Los Angeles
    • San Diego, California, United States, 92093
      • University of California at San Diego
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • Children's Diagnostic and Treatment Center
    • Miami, Florida, United States, 33124
      • University of Miami
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Stoger Hospital of Cook County
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York City, New York, United States, 10128
      • Mt. Sinai Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

A total of up to 300 subjects may be enrolled in the study. The number of subjects in each study group will be as follow: 50 HIV negative subjects; 100 HIV positive subjects with no exposure to ART; and three groups of up to 50 HIV positive subjects each with different ART exposure histories.

Description

Inclusion criteria

• Negative serum or urine pregnancy test if not sterilized
• Tanner Stage 4 or 5
• Accessible medical and medication history
• Willing to fast and complete clinical and laboratory evaluations
• Willingness and ability to give consent or assent with parental permission

Exclusion criteria

• Refusal to fast for 8 hours prior to specimen collection
• Unable to obtain history
• Pregnancy in last 12 months or currently pregnant
• History of anorexia or bulimia
• Type I Diabetes mellitus
• Type II Diabetes mellitus and cannot omit medication for the 48 hour period prior to laboratory specimen collection

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
HIV Negative; HIV negative subjects
HIV Positive - NEVER had ARV therapy.
HIV positive, on a NNRTI, non-PI regimen; HIV positive, currently on a NNRTI, non-PI regimen for at least 3 months. Must NEVER have received a total of more than SIX months of PI-containing regimen and at least ONE year must have passed since receipt of last PI-containing regimen.
HIV positive, on a PI, non-NNRTI regimen; HIV positive, currently on a PI, non-NNRTI regimen for at least 3 months. Must NEVER have received a total of more than SIX months of NNRTI-containing regimen and at least ONE year must have passed since receipt of last NNRTIcontaining regimen.
HIV positive, on a non-PI, non-NNRTI; HIV positive, currently on a non-PI, non-NNRTI containing regimen for at least 3 months. Must NEVER have received a total of more than SIX months of PI- and/or NNRTI- containing regimen and at least ONE year must have passed since receipt of last PI- and/or NNRTI-containing regimen.

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Drug Abuse (NIDA); National Institute on Alcohol Abuse and Alcoholism (NIAAA); National Institute of Mental Health (NIMH)
• Investigators: Study Chair: Grace Aldrovandi, MD, Children's Hospital Los Angeles

Publications and helpful links

Helpful Links

• Description of Adolescent Trials Network (ATN) and contact information

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): June 1, 2005
• Study Completion (Actual): June 1, 2005

Study Registration Dates

• First Submitted: August 25, 2003
• First Submitted That Met QC Criteria: August 25, 2003
• First Posted (Estimate): August 26, 2003

Study Record Updates

• Last Update Posted (Actual): March 1, 2017
• Last Update Submitted That Met QC Criteria: February 27, 2017
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Treatment experienced; Treatment naive
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Glucose Intolerance; Hypercholesterolemia
• Other Study ID Numbers: ATN 021