Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies

• Status: Completed
• Trial end date: 2001-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to see if it is safe and effective to give ritonavir (RTV) plus lamivudine (3TC) plus zidovudine (ZDV) to HIV-infected pregnant women during pregnancy and to their babies after birth.

Pregnant women who are HIV-positive are at risk of giving HIV to their babies during pregnancy or delivery. It is important to learn how to prevent HIV-positive pregnant women from giving HIV to their babies. RTV and ZDV have been shown to be safe and effective against HIV in adults. The combination of 3 anti-HIV drugs (RTV, 3TC, and ZDV) may help prevent HIV infection from mother to infant but studies are needed to determine whether they are safe and effective during pregnancy.

• Phase: Phase 1
• 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: Lamivudine; Ritonavir; Zidovudine

Criteria

Inclusion Criteria

Women may be eligible for this study if they:

• Are HIV-positive.

• Are between 14 and 32 weeks pregnant.

• Are at least 13 years old (consent of parent or guardian required if under 18).

• Have the consent of the baby's father (if he can be reached).

Exclusion Criteria

Women will not be eligible for this study if they:

• Are having problems with their pregnancy.

• Have a history of problem pregnancies including miscarriages, birth defects, stillbirths, or giving birth to premature or low-birth-weight babies.

• Have had side effects to ZDV, 3TC, or RTV.

• Have an active opportunistic (AIDS-related) or other serious infection.

• Have other serious conditions such as heart or lung problems, blood disorders, diabetes, or seizures.

• Are pregnant with more than one baby (such as twins or triplets).

• Are taking other experimental medications.

• Are taking other anti-HIV medications.

• Are taking certain other medications including those for cancer, blood pressure, or seizures.

• Are abusing drugs or alcohol.

• Are breast-feeding.