NCT00000862

Brief Summary

To obtain a pharmacokinetic profile of oral ZDV and to determine whether the oral administration of Zidovudine (ZDV) during labor and delivery will provide a similar profile to that obtained with the use of IV ZDV in ACTG 082. To evaluate the tolerance of oral ZDV in this population, defined as the ability to take oral doses and lack of vomiting within 30 minutes of receiving oral study doses. The worldwide use of constant intrapartum ZDV infusions to prevent transmission is not practical or feasible. Approximately 18% of the women in the ACTG 076 trial missed their IV ZDV infusions, even at experienced ACTG sites. There is an urgent need to establish a more practical method of delivering ZDV during labor and delivery that, at minimum, will approximate the rate of ZDV administration utilized in ACTG 082. In the future, this would enable women to start an intensive ZDV regimen during early labor, even prior to reaching the hospital.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

HIV InfectionsPregnancy

Keywords

PregnancyPregnancy Complications, InfectiousAdministration, OralZidovudineDeliveryLaborAnti-HIV Agents

Interventions

ZidovudineDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A woman may be eligible for this study if:
  • She is HIV-positive.
  • She is at least 34 weeks pregnant.
  • She has a history of at least 4 weeks of continuous oral ZDV during her current pregnancy and tolerated it well.
  • She has given consent for her newborn to participate in this study. (The father must also give consent if he is available after reasonable attempts to contact him. A woman under 18 needs the consent of a parent or legal guardian for her and her infant to participate.)

You may not qualify if:

  • A woman will not be eligible for this study if:
  • She is taking part in another study of HIV treatment during pregnancy.
  • Her infant has a life-threatening illness indicated in an ultrasound.
  • Her infant does not appear to be growing normally in the womb.
  • She has a cesarean section.
  • She has abnormal blood test results.
  • She has severe nausea, vomiting, or other problems of the stomach and intestines at the time of study entry.
  • She has an active opportunistic (AIDS-related) infection or other serious infection at the time of study entry.
  • The study staff cannot find a usable vein.
  • The study doctor feels that she cannot take drugs by mouth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

UCSD Med Ctr / Pediatrics / Clinical Sciences

La Jolla, California, 920930672, United States

Location

UCLA Med Ctr / Pediatric

Los Angeles, California, 900951752, United States

Location

UCSF / Moffitt Hosp - Pediatric

San Francisco, California, 941430105, United States

Location

Univ of California, San Francisco

San Francisco, California, 94143, United States

Location

Univ of Florida Health Science Ctr / Pediatrics

Jacksonville, Florida, 32209, United States

Location

Univ of Miami / Jackson Memorial Hosp

Miami, Florida, 33136, United States

Location

Univ of Miami (Pediatric)

Miami, Florida, 33161, United States

Location

Univ of Medicine & Dentistry of New Jersey / Univ Hosp

Newark, New Jersey, 071032714, United States

Location

Saint Jude Children's Research Hosp of Memphis

Memphis, Tennessee, 381052794, United States

Location

Children's Hosp of the King's Daughters

Norfolk, Virginia, 23507, United States

Location

San Juan City Hosp

San Juan, 009367344, Puerto Rico

Location

MeSH Terms

Conditions

HIV InfectionsPregnancy Complications, Infectious

Interventions

Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Mark Mirochnick

    STUDY CHAIR

  • Pamela Boyer

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

November 1, 2003

Last Updated

October 28, 2021

Record last verified: 2021-10

Locations

US(10)PR(1)