NCT00000917

Brief Summary

The purpose of this study is to set up a blood bank for infants who have HIV-positive mothers. This blood may be used in the future to treat the child if he/she turns out to be HIV-positive. Blood from the umbilical cord contains a certain kind of cell called a stem cell. Stem cells eventually turn into one of the many types of blood cells. If HIV infection can be prevented in these stem cells, then, when these stem cells are injected back into the infant, the new cells that develop will also be protected from HIV. This study will provide the blood needed to test whether this type of gene therapy is safe and effective.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

8 active sites

Status
terminated

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

Study Start

First participant enrolled

September 1, 1997

Completed
2.2 years until next milestone

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
Last Updated

August 1, 2008

Status Verified

June 1, 2003

First QC Date

November 2, 1999

Last Update Submit

July 30, 2008

Conditions

Keywords

Gene TherapySpecimen HandlingBlood BanksFetal Blood

Eligibility Criteria

Age1 Day - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • You may be eligible for this study if you:
  • Are HIV-positive.

You may not qualify if:

  • Your child will not be eligible for this study if he/she:
  • Is not expected to live more than 6 months.
  • Weighs less than 3.3 pounds.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

UCSD Med Ctr / Pediatrics / Clinical Sciences

La Jolla, California, 920930672, United States

Location

Long Beach Memorial (Pediatric)

Long Beach, California, 90801, United States

Location

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

Cedars Sinai / UCLA Med Ctr

Los Angeles, California, 900481804, United States

Location

UCLA Med Ctr / Pediatric

Los Angeles, California, 900951752, United States

Location

Harbor - UCLA Med Ctr / UCLA School of Medicine

Los Angeles, California, 905022004, United States

Location

San Francisco Gen Hosp

San Francisco, California, 94110, United States

Location

UCSF / Moffitt Hosp - Pediatric

San Francisco, California, 941430105, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Savita Pahwa

    STUDY CHAIR
  • Howard Rosenblatt

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Start

September 1, 1997

Last Updated

August 1, 2008

Record last verified: 2003-06

Locations