Search / Trial NCT00000888

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

Trial Information

Current as of December 26, 2024

Completed

Keywords

Pregnancy Pregnancy Complications, Infectious Drug Therapy, Combination Administration, Oral Zidovudine Hiv Protease Inhibitors Ritonavir Disease Transmission, Vertical Anti Hiv Agents Fetal Blood

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.

Trial Officials

Gwendolyn Scott

Study Chair

Univ of Miami (Pediatric)

Mary Jo O'Sullivan

Study Chair

Univ of Miami (Pediatric)

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Miami, Florida, United States

Memphis, Tennessee, United States

Detroit, Michigan, United States

Memphis, Tennessee, United States

Miami, Florida, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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