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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Dyslipidemias Genital Diseases Glucose Intolerance Glucose Metabolism Disorders Hypercholesterolemia Hyperglycemia Hyperlipidemias Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

12 year–24 year

Sex eligibility

Female

Study type

Observational

Primary location

Children's Hopsital of Los Angeles, Los Angeles, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2005
Study completion: 2005
First posted: Aug 26, 2003
Registry last updated: Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed