HIV InfectionsMEPProjectNCT00639145
Elizabeth Glaser Pediatric AIDS Foundation Maternal Events and Pregnancy Outcomes (MEP Project)A Multi-site Protocol
An observational study of HIV Infections and HIV Positive, run by Elizabeth Glaser Pediatric AIDS Foundation at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- HIV Infections, HIV Positive, Pregnant Women
- How many people
- 600 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: HIV positive pregnant women attending ART clinics
Who may be able to join
- 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
Who cannot join
- History of mental illness
- History of condition that would preclude provision of consent
- Inability to provide consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
South Africa1 site
University of Limpopo / Elizabeth Glaser Pediatric AIDS Foundation
Medunsa
About this study
Official title: Maternal Events and Pregnancy Outcomes in a Cohort of Human Immunodeficiency Virus-Infected Women Receiving Antiretroviral Therapy in Sub- Saharan Africa
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.
Read the 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.
- Conditions
- HIV Infections, HIV Positive, Pregnant Women
- Keywords
- HIV, Pregnancy, Antiretrovirals, HIV Seronegativity, Treatment Experienced
- Medical subject headings
- HIV Infections, HIV Seropositivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Congenital birth defects
Number of congenital birth defects among infants born in the study
Measured: At birth
Secondary outcomes (1)
Adverse Pregnancy outcomes
Pregnancy outcomes other than normal live birth such as preterm birth, stillbirth and low birth weight
Measured: At outcome of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startSep 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Centre for Infectious Disease Research in Zambia, University of Limpopo MEDUNSA, Health Systems Trust
- Responsible party
- Sponsor
- Investigators
- Richard Marlink, MD, Principal investigator, Elizabeth Glaser Pediatric AIDS Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639145
- Sponsor's protocol ID
- EG001
- Acronym
- MEPProject
- Status last verified
- Feb 2021
- First submitted
- 14 Mar 2008
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Events and Pregnancy Outcomes in a Cohort of Human Immunodeficiency Virus-Infected Women Receiving Antiretroviral Therapy in Sub- Saharan Africa
- ClinicalTrials.gov ID
- NCT00639145
- Acronym / sponsor ID
- MEPProject / EG001
- Conditions
- HIV Infections, HIV Positive, Pregnant Women
- Keywords
- HIV, Pregnancy, Antiretrovirals, HIV Seronegativity, Treatment Experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Centre for Infectious Disease Research in Zambia, University of Limpopo MEDUNSA, Health Systems Trust
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- HIV positive pregnant women attending ART clinics
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- History of mental illness
- History of condition that would preclude provision of consent
- Inability to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Congenital birth defects
Time frame: At birth
Number of congenital birth defects among infants born in the study
1 secondary outcome
Adverse Pregnancy outcomes
Time frame: At outcome of pregnancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Marlink, MD principal investigator
Elizabeth Glaser Pediatric AIDS Foundation
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and HIV Positive, run by Elizabeth Glaser Pediatric AIDS Foundation at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa, Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Congenital birth defects (time frame: At birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.