Elizabeth Glaser Pediatric AIDS Foundation Maternal Event... | NCT00639145

Studies
Elizabeth Glaser Pediatric AIDS Foundation Maternal Events and Pregnancy Outcomes (MEP Project)A Multi-site Protocol

NCT00639145

Sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Status

Completed

Last Update Posted

Feb 8, 2021Actual

Enrollment

600Actual

Phase

Not provided

Conditions

HIV Infections
HIV Positive
Pregnant Women

Interventions

Not provided

Countries

South Africa
Zambia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Mar 14, 2008

First Submission Date that Met QC Criteria

Mar 19, 2008

First Posted Date

Mar 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2021

Last Update Posted Date

Feb 8, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Elizabeth Glaser Pediatric AIDS FoundationOTHER

Collaborators

Name	Class
Harvard School of Public Health (HSPH)	OTHER
Centre for Infectious Disease Research in Zambia	OTHER
University of Limpopo MEDUNSA	UNKNOWN
Health Systems Trust

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Although the use of HAART in pregnancy has significantly reduced rates of vertical transmission of HIV-1, some questions remain regarding the safety of these therapies and their potential impact on the uninfected infant.

The overall goal of the project is to establish a voluntary exposure-registry and perform observational surveillance on HIV - positive pregnant women who are exposed to antiretroviral products during the prenatal period, in order to evaluate the outcome of the pregnancy and safety of the products in HIV-positive pregnant women, and their infants.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Congenital birth defects	Number of congenital birth defects among infants born in the study	At birth

Secondary Outcomes

Measure	Description	Time Frame
Adverse Pregnancy outcomes	Pregnancy outcomes other than normal live birth such as preterm birth, stillbirth and low birth weight	At outcome of pregnancy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

HIV positive pregnant women attending ART clinics

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Marlink, MD	Elizabeth Glaser Pediatric AIDS Foundation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Limpopo / Elizabeth Glaser Pediatric AIDS Foundation		Medunsa			South Africa
Center for Infectious Disease Research in Zambia (CIDRZ)

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections
D006679	HIV Seropositivity

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided