Search / Trial NCT00000887

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

Trial Information

Current as of December 27, 2024

Completed

Keywords

Pregnancy Pregnancy Complications, Infectious Drug Therapy, Combination Zidovudine Hiv Protease Inhibitors Lamivudine Disease Transmission, Vertical Nelfinavir Anti Hiv Agents

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.

Trial Officials

Yvonne Bryson

Study Chair

Mark Mirochnick

Study Chair

Alice Stek

Study Chair

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

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

Baltimore, Maryland, United States

Chapel Hill, North Carolina, United States

Philadelphia, Pennsylvania, United States

Los Angeles, California, United States

New Orleans, Louisiana, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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