A Study of HIV Levels During Pregnancy and After Childbirth

Completed

Conditions studied: HIV Infections, Pregnancy

In brief

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.

Key facts

Study ID

NCT00041964

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

129

Last updated by the study team

2012-07-24

Who can join

Age: 13 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Los Angeles County Medical Center/USC — Los Angeles, California, United States
• UCLA School of Medicine — Los Angeles, California, United States
• UCSD Mother, Child & Adolescent HIV Program — San Diego, California, United States
• San Francisco General Hosp — San Francisco, California, United States
• Univ of Florida- Health Science Ctr — Jacksonville, Florida, United States
• Emory Univ — Atlanta, Georgia, United States
• University of Hawaii — Honolulu, Hawaii, United States
• Northwestern University — Chicago, Illinois, United States
• Cook County Hosp Core Ctr — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Chicago Childrens Memorial Hospital (Pediatric) — Chicago, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Hutzel Hospital — Detroit, Michigan, United States
• Childrens Hospital of Michigan — Detroit, Michigan, United States
• Hennepin County Med Clinic — Minneapolis, Minnesota, United States
• Univ of Med & Dentistry of NJ/Univ Hosp — Newark, New Jersey, United States
• NYU/Bellevue — New York, New York, United States
• Columbia University — New York, New York, United States
• State Univ of New York at Stony Brook — Stony Brook, New York, United States
• Jacobi Med Ctr — The Bronx, New York, United States
• Univ of North Carolina — Chapel Hill, North Carolina, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• Case Western Reserve Univ — Cleveland, Ohio, United States
• MetroHealth Med Ctr — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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