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

Completed · Phase 1

Conditions studied: HIV Infections, Pregnancy

In brief

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.

Key facts

Study ID

NCT00000888

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

14

Expected to finish

2001-04-01

Last updated by the study team

2021-10-29

Who can join

Age: 13 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Univ. of Miami Miller School of Medicine - Jackson Memorial Hosp. — Miami, Florida, United States
• Univ. of Miami Ped. Perinatal HIV/AIDS CRS — Miami, Florida, United States
• Children's Hospital of Michigan NICHD CRS — Detroit, Michigan, United States
• Regional Med Ctr at Memphis — Memphis, Tennessee, United States
• St. Jude/UTHSC CRS — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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