Clinical trial NCT00067587: Metabolic Abnormalities in HIV Infected and Uninfected Young Women
Official title: Prevalence of Morphologic and Metabolic Abnormalities in HIV Infected and Uninfected Young Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Hypercholesterolemia
Glucose Intolerance
Keywords: Treatment experienced
Treatment naive
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2003-08-26
Enrollment: 300
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hopsital of Los Angeles
state: California
city: San Diego
country: United States
facility: University of California at San Diego
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Children's Diagnostic and Treatment Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Stoger Hospital of Cook County
state: Illinois
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York City
country: United States
facility: Mt. Sinai Hospital
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital Los Angeles
name: Grace Aldrovandi, MD
role: STUDY_CHAIR
References: