Metabolic Abnormalities in HIV Infected and Uninfected Young Women

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067587
• Other study ID #: ATN 021
• Status: Completed
• Phase: N/A
• First received: August 25, 2003
• Last updated: February 27, 2017
• Start date: July 2003
• Est. completion date: June 2005

Study information

• Verified date: February 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• HIV Infections
• Hypercholesterolemia

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Stoger Hospital of Cook County	Chicago	Illinois
United States	Children's Diagnostic and Treatment Center	Fort Lauderdale	Florida
United States	Children's Hopsital of Los Angeles	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Tulane University	New Orleans	Louisiana
United States	Mt. Sinai Hospital	New York City	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of California at San Diego	San Diego	California
United States	University of South Florida	Tampa	Florida
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

External Links

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