Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy
HIV Infections, Pregnancy
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Pregnancy Complications, Infectious, HIV Protease Inhibitors, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Combivir, Treatment Naive
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Usc La Nichd Crs
- UCSD Mother-Child-Adolescent Program CRS
- UCSF Pediatric AIDS CRS
- Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
- Howard Univ. Washington DC NICHD CRS
- Univ. of Miami Miller School of Medicine - Jackson Memorial Hosp.
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
- Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
- Columbus Regional HealthCare System, The Med. Ctr.
- Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
- Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic
- Tulane/LSU Maternal/Child CRS
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
- BMC, Div. of Ped Infectious Diseases
- Brigham and Women's Hosp., Div. of Infectious Disease
- Baystate Health, Baystate Med. Ctr.
- WNE Maternal Pediatric Adolescent AIDS CRS
- Children's Hospital of Michigan NICHD CRS
- Univ. of Mississippi Med. Ctr Children's Hosp.
- Rutgers - New Jersey Medical School CRS
- Bronx-Lebanon Hosp. IMPAACT CRS
- Montefiore Med. Ctr. - AECOM
- Nyu Ny Nichd Crs
- Columbia IMPAACT CRS
- Strong Memorial Hospital Rochester NY NICHD CRS
- SUNY Stony Brook NICHD CRS
- SUNY Upstate Med. Univ., Dept. of Peds.
- DUMC Ped. CRS
- Univ. of Cincinnati CRS
- Case CRS
- MetroHealth CRS
- Oregon Health & Science Univ. - Dept. of Peds., Div. of Infectious Disease
- Regional Med. Ctr. at Memphis
- St. Jude/UTHSC CRS
- Vanderbilt Univ. Med. Ctr., Div. of Ped. Infectious Diseases
- Texas Children's Hosp. CRS
- Univ. of Washington NICHD CRS
- UW Medicine - Harborview Med. Ctr., Northwest Family Ctr.
- UW School of Medicine - CHRMC
- Seattle Children's Hospital CRS
- Princess Margaret Hosp. Bahamas NICHD CRS
- SOM Federal University Minas Gerais Brazil NICHD CRS
- Hosp. dos Servidores Rio de Janeiro NICHD CRS
- Hosp. dos Servidores do Estado CRS
- San Juan City Hosp. PR NICHD CRS