Metabolic Abnormalities in HIV Infected and Uninfected Young Women

NCT ID: NCT00067587

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2005-06-30

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.

Conditions

HIV Infections; Hypercholesterolemia; Glucose Intolerance

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

HIV Negative

HIV negative subjects

No interventions assigned to this group

HIV Positive - NEVER had ARV therapy.

HIV Positive - NEVER had ARV therapy.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grace Aldrovandi, MD

Role: STUDY_CHAIR

Children's Hospital Los Angeles

Locations

Children's Hopsital of Los Angeles

Los Angeles, California, United States

University of California at San Diego

San Diego, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Children's Diagnostic and Treatment Center

Fort Lauderdale, Florida, United States

University of Miami

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

Stoger Hospital of Cook County

Chicago, Illinois, United States

Tulane University

New Orleans, Louisiana, United States

Mt. Sinai Hospital

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

http://www.atnonline.org

Description of Adolescent Trials Network (ATN) and contact information

Other Identifiers

ATN 021

Identifier Type: -

Identifier Source: org_study_id