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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Prevalence of Morphologic and Metabolic Abnormalities in HIV Infected and Uninfected Young Women|
|Study Start Date:||July 2003|
|Study Completion Date:||June 2005|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
HIV negative subjects
HIV Positive - NEVER had ARV therapy.
HIV Positive - NEVER had ARV therapy.
HIV positive, on a NNRTI, non-PI regimen
HIV positive, currently on a NNRTI, non-PI regimen for at least 3 months. Must NEVER have received a total of more than SIX months of PI-containing regimen and at least ONE year must have passed since receipt of last PI-containing regimen.
HIV positive, on a PI, non-NNRTI regimen
HIV positive, currently on a PI, non-NNRTI regimen for at least 3 months. Must NEVER have received a total of more than SIX months of NNRTI-containing regimen and at least ONE year must have passed since receipt of last NNRTIcontaining regimen.
HIV positive, on a non-PI, non-NNRTI
HIV positive, currently on a non-PI, non-NNRTI containing regimen for at least 3 months. Must NEVER have received a total of more than SIX months of PI- and/or NNRTI- containing regimen and at least ONE year must have passed since receipt of last PI- and/or NNRTI-containing regimen.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067587
|United States, California|
|Children's Hopsital of Los Angeles|
|Los Angeles, California, United States, 90027|
|University of California at San Diego|
|San Diego, California, United States, 92093|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010|
|United States, Florida|
|Children's Diagnostic and Treatment Center|
|Fort Lauderdale, Florida, United States, 33316|
|University of Miami|
|Miami, Florida, United States, 33124|
|University of South Florida|
|Tampa, Florida, United States, 33606|
|United States, Illinois|
|Stoger Hospital of Cook County|
|Chicago, Illinois, United States, 60612|
|United States, Louisiana|
|New Orleans, Louisiana, United States, 70112|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|Mt. Sinai Hospital|
|New York City, New York, United States, 10128|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Grace Aldrovandi, MD||Children's Hospital Los Angeles|