Metabolic Abnormalities in HIV Infected and Uninfected Young Women

Completed

• Conditions: Glucose Intolerance; Hypercholesterolemia; HIV Infections

• Registration Number: NCT00067587
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2003-08-25
• Study First Submitted QC: 2003-08-25
• Study First Posted: 2003-08-26
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Status Verified: 2016-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (11)

Tulane University; 🇺🇸 New Orleans, Louisiana, United States

Children's Diagnostic and Treatment Center; 🇺🇸 Fort Lauderdale, Florida, United States

Stoger Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Hopsital of Los Angeles; 🇺🇸 Los Angeles, California, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

University of California at San Diego; 🇺🇸 San Diego, California, United States

Mt. Sinai Hospital; 🇺🇸 New York City, New York, United States

University of Miami; 🇺🇸 Miami, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States