Status:
COMPLETED
Comparison of Anti-HIV Drug Combinations to Prevent Mother-to-Child Transmission of HIV
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
FEMALE
13+ years
Phase:
PHASE3
Brief Summary
Pregnant women infected with HIV who take anti-HIV medications during pregnancy lower the risk of passing HIV to their infants. This study will compare how well two different combinations of anti-HIV ...
Detailed Description
Antiretroviral therapy (ART) in pregnancy has dramatically reduced the rates of perinatal HIV transmission. Many pregnant women infected with HIV may not meet the criteria for treatment as set forth b...
Eligibility Criteria
Inclusion
- Note: The pharmacokinetics testing portion of this study has been discontinued in Version 2.0 of this protocol.
- Inclusion Criteria for Mothers:
- HIV infected
- Between the 12th and 30th week of pregnancy
- Intend to continue pregnancy
- Viral load less than 55,000 copies/ml within 30 days of study entry
- CD4 count greater than 350 cells/ml within 30 days of study entry
- Have not previously taken anti-HIV medications (women who have taken 8 weeks or fewer of zidovudine are still eligible) OR have taken anti-HIV medication but have been off treatment for more than 180 days
- Intend to stop taking anti-HIV medications after pregnancy
- Willing to have her infant tested for HIV
- Parent or guardian willing to provide informed consent, if applicable
- Have access to a participating site and are willing to be followed for the duration of the study
- Exclusion Criteria for Mothers:
- Chemotherapy for active cancer
- Active opportunistic infection or severe medical condition within 14 days of study entry
- Chronic diarrhea within 1 month of study entry or unresolved acute diarrhea within 7 days of study entry
- Certain abnormal laboratory values
- Diabetes mellitus when not pregnant. Participants who have gestational diabetes are not excluded.
- Current alcohol or other substance abuse that, in the opinion of the investigator, may interfere with the study
- Acute hepatitis within 90 days of study entry
- Major birth defects in infant
- Severe skin disorder (e.g., eczema or psoriasis) requiring systemic treatment
- Require certain medications
- Medical condition that may, in the opinion of the investigator, interfere with the study
- Intend to breastfeed
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00086359
Start Date
July 1 2004
End Date
September 1 2007
Last Update
November 1 2021
Active Locations (8)
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1
Usc La Nichd Crs
Los Angeles, California, United States, 90033
2
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States, 92103
3
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States, 33136
4
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
Chicago, Illinois, United States, 60608