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Problems Associated with the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Problems Associated with the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Problems Associated with the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women Clinical research trials and Problems Associated with the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Problems Associated with the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women. Problems Associated with the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Problems Associated with the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women clinical trial. Participants frequently obtain the most expert healthcare available for their Problems Associated with the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Problems Associated with the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women  Problems Associated with the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women
Problems Associated with the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women
For Condition: HIV Infections,Pregnancy
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History, Case Control
Minimum Age/Maximum Age: 13 Years/
Genders: Female
Protocol Entry Criteria: 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.
Total Enrollment: 160
Location and Contact Information:
Overall Study Official:
ElizabethLivingston, Study Chair,
Case Western Reserve Univ *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Michael Chance 216-844-8051
Univ of Marlyand (Pediatric) *Recruiting*
Baltimore, Maryland, 20201
United States
Recruiting Mary MacFadden 410-706-8933
Univ of Medicine & Dentistry of New Jersey / Univ Hosp *Recruiting*
Newark, New Jersey, 071032714
United States
Recruiting Mary Hoyt 973-972-3118
Univ of Alabama at Birmingham - Pediatric *Recruiting*
Birmingham, Alabama, 35233
United States
Recruiting Terry Byars 205-558-2328
Univ of Cincinnati *Recruiting*
Cincinnati, Ohio, 452670405
United States
Recruiting Tammy Powell 513-584-8373
Saint Jude Children's Research Hosp of Memphis *Recruiting*
Memphis, Tennessee, 381052794
United States
Recruiting Jill Utech 901-495-3490
Univ of Washington *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Jeanne Conley 206-731-8877
Univ of Minnesota *Recruiting*
Minneapolis, Minnesota, 55455-0392
United States
Recruiting Christine Fietzer 612-625-1462
Hennepin County Med Ctr *Recruiting*
Minneapolis, Minnesota, 554145
United States
Recruiting Ellen Kane 612-347-2690
Los Angeles County - USC Med Ctr *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Eva Operskalski 323-226-2342
The Med Ctr Inc *Recruiting*
Columbus, Georgia, 31901
United States
Recruiting Dawn Barnes 706-571-1449
Wishard Hosp *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Scott Hamilton 317-630-6023
Brigham and Womens Hosp *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Carolyn Koziol 617-732-5635
Vanderbilt Univ Med Ctr *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Janet Nicotera 615-467-0154
Univ of North Carolina *Recruiting*
Chapel Hill, North Carolina, 27514
United States
Recruiting Cheryl Marcus 919-843-8761
Univ of Florida Health Science Ctr / Pediatrics *No longer recruiting*
Jacksonville, Florida, 32209
United States
No longer recruiting
Metropolitan Hosp Ctr *No longer recruiting*
New York City, New York, 10029
United States
No longer recruiting
Jacobi Med Ctr *Recruiting*
Bronx, New York, 10016
United States
Recruiting Wanda Biernick 718-918-4903
Univ of Miami (Pediatric) *Recruiting*
Miami, Florida, 33161
United States
Recruiting Patricia Bryan 305-243-2154
Bellevue Hosp / New York Univ Med Ctr *Recruiting*
New York City, New York, 10016
United States
Recruiting Maura Laverty 212-263-6565
Hutzel Hospital *Recruiting*
Detroit, Michigan, 48201-1427
United States
Recruiting Dianne Allen 313-993-2681
Howard Univ Hosp *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Patricia Yu 202-865-4578
Univ of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Christine Tripoli 412-647-0771
MetroHealth Med Ctr *Recruiting*
Cleveland, Ohio, 441091998
United States
Recruiting Richard McVey 216-778-5489
The CORE Ctr *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Joanne Despotes 312-572-4545
Rush Presbyterian - Saint Luke's Med Ctr *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Jan Fritsche 312-942-5865
Washington Univ (St.Louis) *Recruiting*
St. Louis, Missouri, 63108-2138
United States
Recruiting Michael Klebert 314-454-0058
Univ of Massachusetts Med School *Recruiting*
Worcester, Massachusetts, 016550001
United States
Recruiting Donna Christian 508-856-1692
Methodist Hosp of Indiana / Life Care Clinic *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Sarah Ryan 317-929-2917
Univ of Hawaii *Recruiting*
Honolulu, Hawaii, 96816-2396
United States
Recruiting Debra Ogata-Arakaki 808-737-2751
Children's Hospital & Medical Center / Seattle ACTU *Recruiting*
Seattle, Washington, 981050371
United States
Recruiting Kathleen Mohan 206-528-5020
Baystate Med Ctr of Springfield *Recruiting*
Springfield, Massachusetts, 01199
United States
Recruiting MariPat Toye 413-794-5399
Duke Univ Med Ctr *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Suzanne Aycock 919-684-8216
Children's Hosp of Michigan *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Charnell Cromer 313-745-7857
Univ of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Carol Greisberger 716-275-5871
St Peter's Med Ctr *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Marian Lake 732-745-8600
San Juan City Hosp *Recruiting*
San Juan, , 009367344
Puerto Rico
Recruiting Maria Pilar Thurin 787-765-4186
Indiana Univ Hosp *Recruiting*
Indianapolis, Indiana, 462025250
United States
Recruiting Beth Zwickl 317-274-8456
Mt Sinai Hosp Med Ctr / Dept of Pediatrics *Recruiting*
Chicago, Illinois, 60608
United States
Recruiting D'andrea Freemon 773-257-5717
Additional Information:
Study ID Numbers: ACTG A5084; AACTG A5084
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017797
Other Pregnancy Studies:
1. Comparison of Two Anti-HIV Regimens that Include One of Two Forms of Didanosine (ddI)
2. Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Patients Following Failure with Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART
3. An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
4. A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC.
5. Rifabutin Therapy for the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
Related Studies:
Other Pregnancy Clinical Trials
Other Minnesota Clinical Trials
Other Minneapolis Clinical Trials
Problems Associated with the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women
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