NCT00639145

Brief Summary

The purpose of this study is to find out if antiretroviral drugs are safe and well tolerated by HIV-positive pregnant women and their infants in South Africa and Zambia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
2.5 years until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

2.3 years

First QC Date

March 14, 2008

Last Update Submit

February 3, 2021

Conditions

HIV InfectionsHIV PositivePregnant Women

Keywords

HIVPregnancyAntiretroviralsHIV SeronegativityTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Number of Congenital birth defects

    Number of congenital birth defects among infants born in the study

    At birth

Secondary Outcomes (1)

  • Adverse Pregnancy outcomes

    At outcome of pregnancy

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

HIV positive pregnant women attending ART clinics

You may qualify if:

  • HIV positive pregnant woman on antiretroviral treatment
  • Able and willing to participate and provide informed consent
  • Be at least 18 years of age or older than legal age to provide consent
  • If under legal age, must have legal guardian who is able to give consent
  • Be an emancipated minor

You may not qualify if:

  • History of mental illness
  • History of condition that would preclude provision of consent
  • Inability to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Limpopo / Elizabeth Glaser Pediatric AIDS Foundation

Medunsa, South Africa

Location

Center for Infectious Disease Research in Zambia (CIDRZ)

Lusaka, Zambia

Location

MeSH Terms

Conditions

HIV InfectionsHIV Seropositivity

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

  • Richard Marlink, MD

    Elizabeth Glaser Pediatric AIDS Foundation

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 14, 2008

First Posted

March 20, 2008

Study Start

September 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 8, 2021

Record last verified: 2021-02

Locations

ZA(1)