Metabolic Abnormalities in HIV Infected and Uninfected Young Women
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00067587|
Recruitment Status : Completed
First Posted : August 26, 2003
Last Update Posted : March 1, 2017
|Condition or disease|
|HIV Infections Hypercholesterolemia Glucose Intolerance|
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.
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|Official Title:||Prevalence of Morphologic and Metabolic Abnormalities in HIV Infected and Uninfected Young Women|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||June 2005|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|