NCT01616823

Brief Summary

In optimally managed HIV+ women with undetectable viral loads, who are on HAART and also receiving intrapartum IV ZDV, the risk of vertical transmission of HIV is independent of the length of time of rupture of membranes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

February 29, 2012

Last Update Submit

February 20, 2019

Conditions

Human Immunodeficiency VirusHIV

Keywords

Human immunodeficiency virus (HIV) positive women

Outcome Measures

Primary Outcomes (1)

  • Mode of delivery

    In optimally managed HIV+ women with undetectable viral loads and on HAART, receiving intrapartum IV ZDV, the risk of vertical transmission of HIV is independent of the length of time of rupture of membranes (as a secondary measure)

    Ten years

Secondary Outcomes (1)

  • Median length of time of membrane rupture

    Ten Years

Study Arms (1)

HIV Positive Women

HIV positive women in two downtown Toronto, Ontario academic-affiliated hospitals

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Total of 210 women from two downtown Toronto, Ontario academic-affiliated hospitals

You may qualify if:

  • all HIV positive women from January 2000

You may not qualify if:

  • women not on HAART and who were not receiving intrapartum intravenous zidovudine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mark Yudin, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2012

First Posted

June 12, 2012

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

February 22, 2019

Record last verified: 2019-02

Locations

CA(1)