Glucose Intolerance, HIV Infections, Hypercholesterolemia
Conditions
Keywords
Treatment experienced, Treatment naive
Brief 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.
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.
Interventions
None listed
Sponsors
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of North Carolina, Chapel Hill
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 24 Years
Healthy volunteers
Yes
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
Countries
United States
Outcome results
None listed