A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given With Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants

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

Keywords

ClinConnect Summary

Despite the dramatic reduction of perinatal HIV transmission by the administration of ZDV to mother and infant, new and more potent strategies are needed to further reduce perinatal transmission and better suit the diverse treatment needs of these patients. Initiation of triple antiretroviral combinations during gestation, particularly combinations that include drugs that cross the placenta such as 3TC, may be the most effective in reducing maternal virus load to its lowest levels prior to delivery.

Women receive nelfinavir plus 3TC plus ZDV antepartum (Study Day 0 until onset of active la...

Gender

FEMALE

Eligibility criteria

• • Inclusion Criteria
• Patients may be eligible for this study if they:
• • Are at least 13 years old (need consent of parent or guardian if under 18).
• • Are HIV-positive.
• • Are in the 2nd or 3rd trimester (14 to 34 weeks pregnant) and are pregnant with one or two children.
• • Have a normal ultrasound exam.
• • Exclusion Criteria
• Patients will not be eligible for this study if they:
• • Cannot take ZDV or 3TC.
• • Have an active opportunistic (HIV-associated) or bacterial infection, or a severe medical condition.
• • Have severe diarrhea.
• • Are at risk for premature birth or pregnancy complications.
• • Have a family history of phenylketonuria (PKU).
• • Plan to breast-feed.
• • Abuse alcohol or drugs.
• • Cannot visit the same clinic for the duration of the study.
• • Have taken certain anti-HIV drugs.