Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: HIV Protease Inhibitors; Lamivudine; Lamivudine, zidovudine drug combination; Nelfinavir; Nevirapine; Protease Inhibitors; Zidovudine

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