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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00017797

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

160

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Pregnancy

Detailed 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.

Study Design

Study Type:

Observational

Observational Model:

Case-Control

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham - Pediatric	Birmingham	Alabama	United States	35233
2	Los Angeles County - USC Med Ctr	Los Angeles	California	United States	90033
3	Yale University School of Medicine	New Haven	Connecticut	United States	06504
4	Howard Univ Hosp	Washington	District of Columbia	United States	20060
5	Univ of Florida Health Science Ctr / Pediatrics	Jacksonville	Florida	United States	32209
6	Univ of Miami (Pediatric)	Miami	Florida	United States	33161
7	The Med Ctr Inc	Columbus	Georgia	United States	31901
8	Univ of Hawaii	Honolulu	Hawaii	United States	96816-2396
9	Mt Sinai Hosp Med Ctr / Dept of Pediatrics	Chicago	Illinois	United States	60608
10	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
11	The CORE Ctr	Chicago	Illinois	United States	60612
12	Indiana Univ Hosp	Indianapolis	Indiana	United States	462025250
13	Methodist Hosp of Indiana / Life Care Clinic	Indianapolis	Indiana	United States	46202
14	Wishard Hosp	Indianapolis	Indiana	United States	46202
15	Univ of Marlyand (Pediatric)	Baltimore	Maryland	United States	20201
16	Brigham and Womens Hosp	Boston	Massachusetts	United States	02215
17	Baystate Med Ctr of Springfield	Springfield	Massachusetts	United States	01199
18	Univ of Massachusetts Med School	Worcester	Massachusetts	United States	016550001
19	Hutzel Hospital	Detroit	Michigan	United States	48201-1427
20	Children's Hosp of Michigan	Detroit	Michigan	United States	48201
21	Hennepin County Med Ctr	Minneapolis	Minnesota	United States	554145
22	Univ of Minnesota	Minneapolis	Minnesota	United States	55455-0392
23	Washington Univ (St.Louis)	St.Louis	Missouri	United States	63108-2138
24	St Peter's Med Ctr	New Brunswick	New Jersey	United States	08903
25	Univ of Medicine & Dentistry of New Jersey / Univ Hosp	Newark	New Jersey	United States	071032714
26	Jacobi Med Ctr	Bronx	New York	United States	10016
27	Bellevue Hosp / New York Univ Med Ctr	New York	New York	United States	10016
28	Metropolitan Hosp Ctr	New York	New York	United States	10029
29	Univ of Rochester Medical Center	Rochester	New York	United States	14642
30	Univ of North Carolina	Chapel Hill	North Carolina	United States	27514
31	Duke Univ Med Ctr	Durham	North Carolina	United States	27710
32	Univ of Cincinnati	Cincinnati	Ohio	United States	452670405
33	Case Western Reserve Univ	Cleveland	Ohio	United States	44106
34	MetroHealth Med Ctr	Cleveland	Ohio	United States	441091998
35	Univ of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
36	Saint Jude Children's Research Hosp of Memphis	Memphis	Tennessee	United States	381052794
37	Vanderbilt Univ Med Ctr	Nashville	Tennessee	United States	37203
38	Univ of Washington	Seattle	Washington	United States	98104
39	Children's Hospital & Medical Center / Seattle ACTU	Seattle	Washington	United States	981050371
40	San Juan City Hosp	San Juan		Puerto Rico	009367344