Problems Associated With the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women

HIV Infections Clinical Trial

Official title:

Evaluation of Metabolic Complications Associated With Antiretroviral Medications in HIV-1-Infected Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00017797
• Other study ID #: ACTG A5084
• Secondary ID: AACTG A5084
• Status: Completed
• Phase: N/A
• First received: June 12, 2001
• Last updated: August 3, 2006

Study information

• Verified date: August 2006
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to find out if HIV-infected pregnant women who take protease inhibitors (PIs) are more likely to have blood sugar problems than those who do not take PIs.

HIV-infected people generally are treated with a combination of different types of anti-HIV drugs, 1 of which is usually a PI. The same holds true for pregnant women, but not much is known about the use of these drugs in pregnancy. Blood sugar and liver problems caused by anti-HIV drugs in nonpregnant patients are well known but their effects in pregnancy are not. Also, certain physical changes brought about by pregnancy may affect the way drugs are handled in the body. There remains a need for further study into the use of anti-HIV drugs during pregnancy and their effect on the safety of the mother and baby.

Description:

The dramatic impact of potent combination antiretroviral therapies on the course of HIV disease has made the use of PIs routine in the care of HIV-1-infected individuals. Combination therapy likewise has become the standard of care in pregnant individuals, even though information on use of these drugs during human pregnancy is limited. There are no published prospective evaluations of toxicities experienced by pregnant women on PI-containing antiretroviral regimens, despite findings of metabolic disturbances of glucose, fatty acids, and cholesterol, as well as lactic acidosis/hepatic steatosis in nonpregnant individuals treated with antiretrovirals. Gastrointestinal (GI) side effects also are well documented in nonpregnant individuals treated with PIs, but have not been systematically evaluated in pregnancy. In addition, the physiologic changes brought about by pregnancy may influence the pharmacokinetics, safety, and side effects of antiretroviral drugs. There remains a need for further evaluation of the use of antiretrovirals during pregnancy and their impact on maternal, fetal, and infant safety.

Patients are stratified according to whether or not they are on a PI-containing antiretroviral regimen and the number of weeks of gestation (26 weeks or less versus greater than 26 weeks). Patients are followed at 8-week intervals from the time of entry until delivery or pregnancy termination, with an additional visit at 12 weeks after delivery or pregnancy termination. All infants born to study participants are evaluated at the time of delivery (anthropometrics and HIV DNA PCR) and are seen again at the mothers' 12-week post-delivery visit. Glucose tolerance testing and other metabolic studies are performed serially during pregnancy and again postpartum. This is an observational study and drugs are not supplied. Patients receiving antiretroviral therapy must obtain their own medications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years and older

Eligibility

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Are female and 13 years of age or older.

• Are between 20 and 34 weeks pregnant at study entry.

• Had an ultrasound performed at 16 or more weeks of pregnancy.

• Have consent of a parent or guardian if under 18 years of age. The father of the baby, if available, also must give consent.

• Have taken the same anti-HIV drugs, including a PI, during the 8 weeks just before study entry. If not taking a PI or any anti-HIV drug, must not have taken a PI during the 8 weeks just before study entry. Patients must carry on this way for the entire study.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have diabetes. Patients who have had diabetes caused by pancreas problems or steroid use in the past, but now have normal blood sugar without having to take drugs or special diets, are allowed. Patients who have had blood sugar problems in a past pregnancy also are allowed.

• Had a serious infection or medical condition within 30 days before study entry.

• Are enrolled in another study which requires a lot of blood tests.

• Take, or have taken in the 6 weeks before study entry, any of the following drugs:

hormones (growth hormone, testosterone, or steroids), thalidomide, interleukins or interferons, efavirenz, hydroxyurea, drugs to control blood sugar, and anti-cancer drugs.

• Take, or have taken in the year before study entry, steroids, e.g., prednisone, for more than 14 days in any 3-month period. Inhaled steroids and steroid creams/ointments are allowed.

• Take, or have taken in the 30 days before study entry, PIs with lovastatin or simvastatin (2 drugs that lower the amount of fat in the blood).

• Have an ultrasound showing a major abnormality in the baby.

• Have problems with their pregnancy and/or are expecting more than 1 baby.

• Abuse drugs or alcohol.

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• HIV Infections
• Pregnancy

Locations

Country	Name	City	State
Puerto Rico	San Juan City Hosp	San Juan
United States	Univ of Marlyand (Pediatric)	Baltimore	Maryland
United States	Univ of Alabama at Birmingham - Pediatric	Birmingham	Alabama
United States	Brigham and Womens Hosp	Boston	Massachusetts
United States	Jacobi Med Ctr	Bronx	New York
United States	Univ of North Carolina	Chapel Hill	North Carolina
United States	Mt Sinai Hosp Med Ctr / Dept of Pediatrics	Chicago	Illinois
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	The CORE Ctr	Chicago	Illinois
United States	Univ of Cincinnati	Cincinnati	Ohio
United States	Case Western Reserve Univ	Cleveland	Ohio
United States	MetroHealth Med Ctr	Cleveland	Ohio
United States	The Med Ctr Inc	Columbus	Georgia
United States	Children's Hosp of Michigan	Detroit	Michigan
United States	Hutzel Hospital	Detroit	Michigan
United States	Duke Univ Med Ctr	Durham	North Carolina
United States	Univ of Hawaii	Honolulu	Hawaii
United States	Indiana Univ Hosp	Indianapolis	Indiana
United States	Methodist Hosp of Indiana / Life Care Clinic	Indianapolis	Indiana
United States	Wishard Hosp	Indianapolis	Indiana
United States	Univ of Florida Health Science Ctr / Pediatrics	Jacksonville	Florida
United States	Los Angeles County - USC Med Ctr	Los Angeles	California
United States	Saint Jude Children's Research Hosp of Memphis	Memphis	Tennessee
United States	Univ of Miami (Pediatric)	Miami	Florida
United States	Hennepin County Med Ctr	Minneapolis	Minnesota
United States	Univ of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt Univ Med Ctr	Nashville	Tennessee
United States	St Peter's Med Ctr	New Brunswick	New Jersey
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Bellevue Hosp / New York Univ Med Ctr	New York	New York
United States	Metropolitan Hosp Ctr	New York	New York
United States	Univ of Medicine & Dentistry of New Jersey / Univ Hosp	Newark	New Jersey
United States	Univ of Pittsburgh	Pittsburgh	Pennsylvania
United States	Univ of Rochester Medical Center	Rochester	New York
United States	Children's Hospital & Medical Center / Seattle ACTU	Seattle	Washington
United States	Univ of Washington	Seattle	Washington
United States	Baystate Med Ctr of Springfield	Springfield	Massachusetts
United States	Washington Univ (St.Louis)	St.Louis	Missouri
United States	Howard Univ Hosp	Washington	District of Columbia
United States	Univ of Massachusetts Med School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Puerto Rico,