|
A Study of HIV Levels During Pregnancy and After Childbirth Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about A Study of HIV Levels During Pregnancy and After Childbirth conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study of HIV Levels During Pregnancy and After Childbirth Clinical research trials and A Study of HIV Levels During Pregnancy and After Childbirth healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as A Study of HIV Levels During Pregnancy and After Childbirth. A Study of HIV Levels During Pregnancy and After Childbirth Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study of HIV Levels During Pregnancy and After Childbirth clinical trial. Subjects frequently obtain the most expert healthcare possible for their A Study of HIV Levels During Pregnancy and After Childbirth condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Study of HIV Levels During Pregnancy and After Childbirth  A Study of HIV Levels During Pregnancy and After Childbirth
A Study of HIV Levels During Pregnancy and After Childbirth
For Condition: HIV Infections,Pregnancy
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to find out if HIV-infected pregnant women taking anti-HIV drugs have an increased amount of HIV in their blood (viral load) after having the baby. The purpose of A5153s, a substudy of A5150, is to characterize two anti-HIV drugs (nelfinavir [NFV] and lopinavir/ritonavir [LPV/r]) in HIV-infected women during pregnancy and after childbirth. Sometimes pregnant women have an increase in their HIV viral load after their baby is born. This study will try to find out how often this happens. It will also examine possible reasons why the increase in viral load occurs.
Details: Limited data suggest that HIV-infected pregnant women develop postpartum viral rebound. However, viral load changes in the postpartum period have not been adequately characterized. Changes in adherence to antiretroviral therapy, pregnancy-related changes in pharmacokinetics of antiretroviral medications, and decline in immune competence are mechanisms by which postpartum viral load rebound may occur. This study is designed to characterize the incidence and magnitude of postpartum viral rebound during the initial 24 weeks postpartum and to explore the mechanisms and consequences of viral rebound. Eligible patients are evaluated at gestational weeks 34 and 36, at delivery, and at regular visits for 96 weeks postpartum. Most evaluations include a medical history, physical exam, laboratory tests, and adherence and quality-of-life questionnaires. Viral load and CD4/CD8 cell counts are measured frequently. Patients are expected to receive at least 8 weeks of stable HAART before delivery, and to continue HAART throughout the remainder of the study. The choice of HAART is left to the primary provider. No antiretroviral drugs are provided by this study. Patients participating in the A5153s substudy receive either NFV or LPV/r as part of their HAART. Pharmacokinetic blood sampling takes place at 36 weeks gestation, 6 weeks postpartum, and 24 weeks postpartum. Patients record the administration times and doses of their NFV or LPV/r for 48 hours prior to each substudy visit, and hold their regularly scheduled doses of antiretroviral medications on substudy days. Patients arrive at the clinic fasting (no food or drink for the previous 8 hours) and are given a standardized breakfast prior to supervised administration of their NFV or LPV/r dose. An intravenous catheter is placed in an arm vein for blood collection at pre-dose and 1, 2, 4, and 6 hours post-dose.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 13 Years/
Genders: Female
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are age 13 or older. - Are between 22 and 30 weeks pregnant. - Have had their pregnancy confirmed by ultrasound at 14 weeks gestation or later. - Are infected with HIV. - Are planning to receive at least 8 weeks of highly active antiretroviral therapy (HAART) by the time they have their baby. - Are available for follow-up for the duration of the study. Exclusion Criteria Patients may not be eligible for this study if they: - Intend to terminate their pregnancy. - Intend to breast-feed their baby. - Are carrying a baby with major abnormalities, including spina bifida, anencephaly, hydrops, or ascites. - Have taken certain medications. - Are enrolled in other studies that require large blood draws. - Will be taking anti-HIV drugs only to prevent mother-to-child transmission of HIV, and not to treat the maternal infection itself. - Actively abuse drugs or alcohol in a way that would interfere with participation in the study.
Total Enrollment: 129
Location and Contact Information:
Overall Study Official:
AliceStek, Study Chair,
State Univ of New York at Stony Brook *Recruiting*
Stony Brook, New York, 11794-8111
United States
Recruiting Michell Davi 631-444-1313
Duke Univ Med Ctr *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Suzanne Aycock 919-684-8216
Cook County Hosp Core Ctr *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Joanne Despotes 315-572-4545
MetroHealth Med Ctr *Recruiting*
Cleveland, Ohio, 44109-1998
United States
Recruiting Ann Conrad 216-778-5489
Rush Presbyterian - Saint Luke's Med Ctr *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Jan Fritsche 312-942-5865
Univ of Med & Dentistry of NJ/Univ Hosp *Recruiting*
Newark, New Jersey, 07103
United States
Recruiting Mary Hoyt 973-972-3118
The Regional Med Ctr, Memphis *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting Laura Utech 901-495-3490
Comprehensive Care Clinic *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Janet Nicotera 615-467-0154
San Francisco General Hosp *Recruiting*
San Francisco, California, 94110
United States
Recruiting Michele Downing 415-514-0550
Univ of Florida- Health Science Ctr *Recruiting*
Jacksonville, Florida, 32209
United States
Recruiting Melissa Scites 904-244-3108
Univ of North Carolina *Recruiting*
Chapel Hill, North Carolina, 27514
United States
Recruiting Cheryl Marcus 919-843-8761
Miriam Hosp / Brown Univ *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-793-4396
Los Angeles County Medical Center/USC *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Eva Operskalski 323-226-2226
Emory Univ *Recruiting*
Atlanta, Georgia, 30308
United States
Recruiting Ericka Patrick 404-616-6313
San Juan City Hosp *Recruiting*
San Juan, ,
Puerto Rico
Recruiting Maria Pilar Thurin 787-765-4186
Case Western Reserve Univ *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Michael Chance 216-844-8051
Univ of Alabama at Birmingham *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting Betty McCulloch 205-975-7925
Jacobi Med Ctr *Recruiting*
Bronx, New York, 10461
United States
Recruiting Wanda Biernick 718-918-4903
Univ of Washington (Seattle) *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Jeanne Conley 206-731-8877
Indiana Univ Hosp *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Beth Zwickl 317-274-8456
Hennepin County Med Clinic *Recruiting*
Minneapolis, Minnesota, 55455-0392
United States
Recruiting Ellen Kane 612-347-2690
UCSD Mother, Child & Adolescent HIV Program *Recruiting*
San Diego, California, 92103
United States
Recruiting Linda Proctor 619-543-8080
University of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213-2582
United States
Recruiting Christine Tripoli 412-647-0771
University of Texas, Southwestern Medical Center *Recruiting*
Dallas, Texas, 75235-9173
United States
Recruiting Chip Lohner 214-590-0414
Additional Information:
Study ID Numbers: ACTG A5150; AACTG A5150,ACTG A5153s,AACTG A5153s
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041964
Other Pregnancy Studies:
1. A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection
2. Changing to Nonprotease Inhibitor Treatment to Improve Side Effects
3. A Study on the Effect of Chemotherapy Combined with Anti-HIV Drugs in HIV-Positive Patients
4. The Safety and Effectiveness of Two Forms of Saquinavir Combined with Other Anti-HIV Drugs in HIV-Infected Infants and Children
5. A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases
Related Studies:
Other Pregnancy Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
A Study of HIV Levels During Pregnancy and After Childbirth
|
|
|
|
|
|
|
|
