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

• Status: Completed
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to see if giving nelfinavir (NFV) plus zidovudine (ZDV) plus lamivudine (3TC) to HIV-positive pregnant women and their babies is safe. This study will also look at how long these drugs stay in the blood.

ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their babies. However, better treatments are needed to further reduce these chances and to better suit the treatment needs of mothers and their children. Taking a combination of anti-HIV drugs during pregnancy may be an answer.

• 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; Nelfinavir; Zidovudine

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.