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Home > "M" Clinical Trials Conditions > Metabolic Abnormalities in HIV Infected and Uninfected Young Women  Metabolic Abnormalities in HIV Infected and Uninfected Young Women
Metabolic Abnormalities in HIV Infected and Uninfected Young Women
For Condition: Glucose Intolerance,HIV Infections,Hypercholesterolemia
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , National Institute on Drug Abuse (NIDA),National Institute of Mental Health (NIMH),National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Synopsis: 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.
Details: 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:
Study Type: Observational, Natural History, Cross-Sectional, Defined Population, Prospective Study
Minimum Age/Maximum Age: 12 Years/24 Years
Genders: Female
Protocol Entry 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
Total Enrollment: 250
Location and Contact Information:
Overall Study Official:
GraceAldrovandi, Study Chair, Children's Hospital Los Angeles
Montefiore Medical Center *Recruiting*
Bronx, New York,
United States
Recruiting Elizabeth Enriquez-Bruce 718-882-0023
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010
United States
Recruiting Connie Trexler 202-884-3714
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania,
United States
Recruiting Mary Tanney 215-590-4954
Stoger Hospital of Cook County *Recruiting*
Chicago, Illinois,
United States
Recruiting Kelly Bojan 312-572-4571
Tulane University *Recruiting*
New Orleans, Louisiana,
United States
Recruiting Leslie Kozina 504-588-5348
Mt. Sinai Hospital *Recruiting*
New York City, New York,
United States
Recruiting Mary Geiger 212-423-2867
Children's Diagnostic and Treatment Center *Recruiting*
Ft. Lauderdale, Florida,
United States
Recruiting Esmine Leonard 954-728-1125
University of California at San Diego *Recruiting*
San Diego, California,
United States
Recruiting Lisa Stangl 619-543-8080
University of South Florida *Recruiting*
Tampa, Florida,
United States
Recruiting Silvia Callejas 813-259-8799
Children's Hopsital of Los Angeles *Recruiting*
Los Angeles, California,
United States
Recruiting Diane Tucker 323-660-2450
University of Miami *Recruiting*
Miami, Florida,
United States
Recruiting Donna Maturo 305-243-3442
Additional Information:
Study ID Numbers: ATN 021;
Study Start Date: July 2003
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067587
Other Hypercholesterolemia Studies:
1. Therapeutic Drug Monitoring and Viral Resistance Testing in the Treatment of HIV-Infected Children
2. A Study to See if Certain Antioxidants and Vitamins Will Keep Lactate Levels Down in Patients Taking Anti-HIV Drugs
3. A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy
4. The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs
5. Treatment of Advanced AIDS Patients with Dextrin Sulfate
Related Studies:
Other Hypercholesterolemia Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Metabolic Abnormalities in HIV Infected and Uninfected Young Women
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