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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Controlled studies of the pharmacokinetics and safety of new drugs are critical to the development of alternative therapies for the prevention of perinatal transmission of HIV-1. The dosing regimen of RTV and ZDV used to treat pregnant women in this study has been shown to be safe and effective against HIV in adults. Little is known about the metabolism and tolerance of these drugs during pregnancy, and Phase I studies are needed to determine dosage, safety, and tolerance. Protease inhibitors in combination with other antiretroviral drugs may help reduce the rate of perinatal transmission o...

Gender

FEMALE

Eligibility 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.