Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy
Completed · Phase 3
Conditions studied: HIV Infections, Pregnancy
In brief
The best anti-HIV treatment regimen for pregnant women is not known. Protease inhibitors (PIs) are often used, but they have side effects that may be harmful for pregnant women. It is not known if treatment regimens that do not include PIs are as effective in pregnant women as those that include PIs. This trial will compare two anti-HIV treatment plans, one with and one without PIs, in women who start HIV treatment during pregnancy. The study will evaluate the effects of the anti-HIV drugs on the developing infant and prevention of mother-to-child HIV transmission during pregnancy.
Key facts
- Study ID
- NCT00017719
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 440
- Starts
- 2002-05-01
- Expected to finish
- 2006-03-01
- Last updated by the study team
- 2021-11-01
Who can join
Age: 14 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- HIV infected
- 10 to 30 weeks pregnant
- Plan to continue pregnancy
- CD4 count less than 250 cells/mm3 within 30 days of study entry
- HIV RNA load greater than 1,000 copies/ml within 30 days of study entry
- Antiretroviral naive (except ZDV for 8 weeks or less, including prior pregnancy)
- Willing to follow study requirements and plan to continue receiving anti-HIV treatment for at least 2 years after delivery
- Understand that NFV will not be supplied by the study (except for the first 12 women in Group A)
- Understand the study drug NVP will not be supplied after 1 year following delivery and is reasonably certain that she can obtain NVP by prescription for the second year of the study
- Access to a participating site
- Willing to have infant followed until 24 weeks old
- Parent or guardian willing to provide informed consent, if applicable
You may not qualify if…
- Alcohol or drug abuse
- Chemotherapy for an active cancer
- Require certain medications
- AIDS-related opportunistic infection and/or serious bacterial infection or unstable or serious medical condition within 14 days of study entry
- Chronic malabsorption or diarrhea
- Diabetes, unless it only occurs during pregnancy
- Major fetal problem or abnormality
- Abnormal amniotic fluid volume
- Plan to breastfeed
- Acute hepatitis within 90 days of study entry
- Skin problems such as psoriasis or eczema that require systemic treatment
- Any serious disease that, in the opinion of the study official, would compromise study participation
Where it is running
- Usc La Nichd Crs — Los Angeles, California, United States
- UCSD Mother-Child-Adolescent Program CRS — San Diego, California, United States
- UCSF Pediatric AIDS CRS — San Francisco, California, United States
- Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases — Torrance, California, United States
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease — New Haven, Connecticut, United States
- Howard Univ. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
- Univ. of Miami Miller School of Medicine - Jackson Memorial Hosp. — Miami, Florida, United States
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS — Miami, Florida, United States
- Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases — Augusta, Georgia, United States
- Columbus Regional HealthCare System, The Med. Ctr. — Columbus, Georgia, United States
- Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program — Chicago, Illinois, United States
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease — Chicago, Illinois, United States
- Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic — New Orleans, Louisiana, United States
- Tulane/LSU Maternal/Child CRS — New Orleans, Louisiana, United States
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases — Baltimore, Maryland, United States
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology — Baltimore, Maryland, United States
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
- BMC, Div. of Ped Infectious Diseases — Boston, Massachusetts, United States
- Brigham and Women's Hosp., Div. of Infectious Disease — Boston, Massachusetts, United States
- Baystate Health, Baystate Med. Ctr. — Springfield, Massachusetts, United States
- WNE Maternal Pediatric Adolescent AIDS CRS — Worcester, Massachusetts, United States
- Children's Hospital of Michigan NICHD CRS — Detroit, Michigan, United States
- Univ. of Mississippi Med. Ctr Children's Hosp. — Jackson, Michigan, United States
- Rutgers - New Jersey Medical School CRS — Newark, New Jersey, United States
- Nyu Ny Nichd Crs — New York, New York, United States
Full record on ClinicalTrials.gov
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