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Home > "A" Clinical Trials Conditions > Anti-HIV Drugs During Pregnancy  Anti-HIV Drugs During Pregnancy
Anti-HIV Drugs During Pregnancy
For Condition: HIV Infections
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 determine what doses of anti-HIV medications are appropriate for pregnant women. Anti-HIV medication taken during pregnancy may control a woman's viral load and reduce the chance that the baby will become infected with HIV. Pregnant women may require different doses of anti-HIV drugs than people who are not pregnant. This study will use pharmacokinetic (PK) sampling (a way to find out how drugs act in the body) to determine what doses of which anti-HIV medications are best for HIV infected pregnant women and their infants.
Details: Pregnant women experience unique physiological changes that may result in clinically significant alterations in drug pharmacokinetics. Unfortunately, there have been few clinical trials to study the pharmacokinetics of antiretroviral drugs in pregnant women. The development of appropriate dosing regimens for the HIV infected pregnant woman is critical to the health of both mother and fetus. Overdosing may lead to maternal adverse events and increased risk of fetal toxicity, while underdosing may lead to inadequate virologic control, increased risk of developing drug resistance mutations, and a higher rate of perinatal HIV transmission. This study will develop and evaluate dosing regimens to identify those that are most effective in preventing perinatal HIV transmission and in maintaining the health of both mother and fetus. Intensive PK sampling is performed at study visits during the third trimester of pregnancy and again between 6 and 12 weeks postpartum. On the day of PK sampling, study visits are scheduled to start in the morning, will last 6 to 12 hours, and will coincide with the end of the previous dosing cycle. At the end of the dosing cycle, the morning dose of the antiretroviral drug(s) is given in the clinic after the predose PK sample is drawn. Serial blood collection is performed with an intravenous catheter that is placed in a vein in each patient's arm. A urine sample is also collected at each visit and a brief medical interview is performed. An intrapartum PK sample is obtained from the patient and from the detached umbilical cord. The patient and clinical caregiver may decide to modify dosing. If they do so, repeat PK sampling is offered at the new dose.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: Inclusion Criteria - HIV infected women who are at least 26 weeks pregnant - Enrollment in PACTG P1025 - Adult dose of nevirapine, amprenavir, abacavir, lopinavir/ritonavir, or off-label dosing of indinavir/ritonavir for at least 1 week before PK sampling - Ability to continue the drug regimen until at least 6 weeks after delivery - Note: If a woman has completed P1026S and becomes pregnant again, she may be eligible to re-enroll in P1026S only if she is receiving a different drug or drug combination than that studied during the first enrollment in P1026S. Exclusion Criteria - Certain medications known to interfere with absorption, metabolism, or clearance of the anti-HIV drug being evaluated - Pregnant with more than one baby - Signs of toxicity that, in the opinion of the site investigator, would be likely to require a change in medication during the study
Total Enrollment: 125
Location and Contact Information:
Overall Study Official:
MarkMirochnick, Study Chair,
Shiara Ortiz-Pujols *Recruiting*
Silver Spring, Maryland, 20910
United States
Recruiting
St. Jude Childrens Research Hospital, Memphis *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting Laura Utech 901-495-3490
Chicago Childrens Memorial Hospital (Pediatric) *Recruiting*
Chicago, Illinois, 60614
United States
Recruiting Stacy Rogers 773-880-3669
Long Beach Memorial (Pediatric) *Recruiting*
Long Beach, California, 90801
United States
Recruiting Susan Marks 562-595-0812
University of Illinois *Recruiting*
Chicago, Illinois, 60612-7234
United States
Recruiting Julia Camacho 312-413-8089
Univ of Puerto Rico, U. Children's Hosp AIDS *Recruiting*
San Juan, , 00936-5067
Puerto Rico
Recruiting Sylvia Nieves 787-759-9595
Jackson Memorial Hosp *Recruiting*
Miami, Florida, 33136
United States
Recruiting Cathie Gamber 305-243-4446
Northwest Family Center/Haborview Medical Center *Recruiting*
Seattle, Washington, 98105-0371
United States
Recruiting Kathleen Mohan 206-987-5020
UCSF, Moffitt Hosp (Pediatric) *Recruiting*
San Francisco, California, 94143-0105
United States
Recruiting Debbie Trevithick 415-476-6480
Univ of Med. & Dentistry of NJ/Univ Hosp *Recruiting*
Newark, New Jersey, 07103
United States
Recruiting Mary Hoyt 973-972-3118
Children's Hospital and Regional Medical Center *Recruiting*
Seattle, Washington, 98105-0371
United States
Recruiting Kathleen Mohan 206-987-5020
St. Louis Children's Hospital *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Laura Pickering 314-454-2576
Bringham and Women's Hospital *Recruiting*
Boston, Massachusetts, 02478
United States
Recruiting Arlene Buck 617-732-5111
The Columbia Presbyterian Med Ctr *Recruiting*
New York City, New York, 10032
United States
Recruiting Marie Donahue 212-305-7222
University Hospital *Recruiting*
New Orleans, Louisiana, 70112-2699
United States
Recruiting Margaret Cowie 504-586-3804
University of Maryland (Pediatrics) *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Mary MacFadden 410-706-8933
UCSD Mother, Child & Adolescent HIV Program *Recruiting*
San Diego, California, 92103
United States
Recruiting Linda Proctor 619-543-8080
The University of Chicago Childrens Hospital *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Pamela Lofton 773-702-3853
University of Washington Medical Center *Recruiting*
Seattle, Washington, 98105-0371
United States
Recruiting Kathleen Mohan 206-987-5020
UCSD Mother, Child, Adolescent HIV Program *Recruiting*
San Diego, California, 92103
United States
Recruiting Linda Proctor 619-543-8080
UCLA Med Ctr (Pediatrics) *Recruiting*
Los Angeles, California, 90090-1752
United States
Recruiting Maryanne Dillon 310-825-9660
Duke University (Pediatric) *Recruiting*
Durham, North Carolina, 27705
United States
Recruiting John Swetnam 919-416-3447
San Juan City Hosp *Recruiting*
San Juan, ,
Puerto Rico
Recruiting Maria Pilar Thurin 787-765-4186
University of Massachusetts Medical School *Recruiting*
Worcester, Massachusetts, 01655-0001
United States
Recruiting Donna Christian 508-856-1692
Boston Medical Center (Pediatric) *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Kirk Bertelsen 617-414-5813
Univ of Miami (Pediatric) *Recruiting*
Miami, Florida, 33136
United States
Recruiting Cathie Gamber 305-243-4446
University of Alabama at Birmingham (Pediatric) *Recruiting*
Birmingham, Alabama, 35233
United States
Recruiting Terry Byars 205-558-2328
Vanderbilt University Medical Center *Recruiting*
Nashville, Tennessee, 37232-2581
United States
Recruiting Peggy Bender 615-322-2250
Jacobi Medical Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Wanda Biermick 718-918-4903
Additional Information:
Study ID Numbers: PACTG P1026S; PACTG P1025
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042289
Other Hiv Infections Studies:
1. The Safety and Effectiveness of HBY 097 Used with or without AZT in HIV-Infected Patients Who Have Mild or No Symptoms
2. A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects
3. Screening Protocol for HIV Vaccine Studies
4. A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine
5. Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated with Zidovudine
Related Studies:
Other HIV Infections Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Anti-HIV Drugs During Pregnancy
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