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.

Condition
HIV Infections Hypercholesterolemia Glucose Intolerance

Further Study Details: 

Expected Total Enrollment:  250

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.

Ages Eligible for Study:  12 Years   -   24 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

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

Nancy Liu, MPH      301-738-3640    nancyliu@westat.com

California
      University of California at San Diego, San Diego,  California,  United States; Recruiting
      Children's Hopsital of Los Angeles, Los Angeles,  California,  United States; Recruiting
District of Columbia
      Children's National Medical Center, Washington,  District of Columbia,  20010,  United States; Recruiting
Florida
      University of Miami, Miami,  Florida,  United States; Recruiting
      University of South Florida, Tampa,  Florida,  United States; Recruiting
      Children's Diagnostic and Treatment Center, Fort Lauderdale,  Florida,  United States; Recruiting
Illinois
      Stoger Hospital of Cook County, Chicago,  Illinois,  United States; Recruiting
Louisiana
      Tulane University, New Orleans,  Louisiana,  United States; Recruiting
New York
      Montefiore Medical Center, Bronx,  New York,  United States; Recruiting
      Mt. Sinai Hospital, New York City,  New York,  United States; Recruiting
Pennsylvania
      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  United States; Recruiting

Study chairs or principal investigators

Grace Aldrovandi, MD,  Study Chair,  Children's Hospital Los Angeles   

Study ID Numbers:  ATN 021
Record last reviewed:  March 2005
Last Updated:  April 1, 2005
Record first received:  August 25, 2003
ClinicalTrials.gov Identifier:  NCT00067587
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08