HIV InfectionsNCT00100867
Effects of Maternal Anti-HIV Treatment on Infants Born to HIV-Infected Women
An observational study of HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 23 sites in 8 countries.
Trial summary
In clinical trials being conducted throughout the world, pregnant HIV-infected women are given anti-HIV drugs before, during, and after they give birth to prevent mother-to-child transmission of HIV. However, the effects of this anti-HIV treatment on infants is unknown. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 236 participants
- Where
- 23 sitesin 8 countries
- Study dates
- Jun 2006to May 2010
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Infants born to HIV-infected women
Who may be able to join
- Infant born to HIV-1 infected mother enrolled in NIH-sponsored, international antiretroviral treatment trial AND who has had either in utero or postpartum antiretroviral exposure
- Parent or guardian willing to provide informed consent
Who cannot join
- Infant with no exposure to antiretrovirals OR who received only intrapartum antiretroviral exposure
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
Thailand7 sites
Bhumibol Adulyadej Hospital, Bangkok
Bangkok, 10120
Siriraj Hospital
Bangkok Noi, Bankok, 10700
Chiang Mai University
Chang Mai
Institut de Recherche pour Developpement (IRD)
Chiang Mai, 50200
Chonburi Regional Hospital, Chonburi
Muang, Changwat Chon Buri, 20000
Prapokklao Hospital Chantaburi
Muang Chantaburi, 22000
Phayao Provincial Hospital, Phayao
Tambol Mae Sai, Muang Phayao, 56000
India4 sites
YRG Center for AIDS Research and Education
Chennai, 60001-7
NARI AIDS Research Institute, Department of Clinical Science
Pune
NARI AIDS Research Institute, Dr. Kotnis Dispensary
Pune
NARI-NIV Clinic
Pune
Brazil3 sites
Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz
Rio de Janeiro, 21045-900
Hospital dos Servidores do Estado
Rio de Janeiro, 22261-161
Hospital Geral de Nova Iguacu
Rio de Janeiro
Botswana2 sites
The Gaborone BHP Study Clinic
Gaborone
The Molepolole BHP Study Clinic
Gaborone
Malawi2 sites
Univ. of Malawi, John Hopkins Project
Blantyre
University of North Carolina Project (UNC Project)
Lilongwe
Peru2 sites
Asociacion Civil IMPACTA Salud y Educacion, Lince
Lima, 18
Asociacion Civil IMPACTA Salud y Educacion,
Miraflores, Lima region, 18
South Africa2 sites
Perinatal HIV Research Unit at Chris Baragwanath Hospital
Johannesburg
University of the Witwatersrand
Johannesburg
About this study
Official title: Assessment of Safety and Toxicity Among Infants Born to HIV-1-Infected Women Enrolled in Antiretroviral Treatment Protocols in Diverse Areas of the World
In clinical trials being conducted throughout the world, pregnant HIV-infected women are given anti-HIV drugs before, during, and after they give birth to prevent mother-to-child transmission of HIV. However, the effects of this anti-HIV treatment on infants is unknown. The purpose of this study is to determine the safety, toxicity, and potential side effects of maternal anti-HIV treatment on infants born to these HIV-infected women.
Study hypothesis: Specific combination antiretroviral regimens used in clinical trials in diverse areas of the world are safe and well tolerated during pregnancy and breastfeeding periods, and are not associated with adverse side effects to the fetus, neonate, and/or breastfeeding infant. These regimens are associated with reduction of mother-to-child HIV transmission.
Read the detailed description
Many HIV-infected women outside the United States enroll in clinical trials that provide them antiretroviral therapy (ART) to prevent mother-to-child transmission of HIV. However, data are limited on the safety, toxicity, and adverse effects that maternal ART may have on infants born to HIV-infected women. This study will monitor the adverse effects and potential benefits of maternal ART on these infants.
No antiretrovirals will be given in this study. This study will last 18 months. Infants will be enrolled in the study within 48 hours of birth. There will be 6 study visits starting at study entry and every 6 weeks thereafter. Infants will undergo blood and urine collection, and medical history assessments will occur at every visit. Mothers will also be evaluated at these visits.
- Conditions
- HIV Infections
- Keywords
- Perinatal Transmission, Mother-to-Child Transmission
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2005 (estimated)
- Study startJun 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Karin Nielsen, MD, MPH, Study chair, University of California, Los AngelesJudith S. Currier, MD, MSc, Study chair, Center for AIDS Research and Education, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100867
- Sponsor's protocol ID
- ACTG A5190-P1054
- Other IDs
- 1U01AI068636
- Status last verified
- Mar 2016
- First submitted
- 6 Jan 2005
- Last updated
- 1 Apr 2016
- Results posted
- No
Publications
Abrams EJ. Prevention of mother-to-child transmission of HIV--successes, controversies and critical questions. AIDS Rev. 2004 Jul-Sep;6(3):131-43.
PubMed 15595430Scarlatti G. Mother-to-child transmission of HIV-1: advances and controversies of the twentieth centuries. AIDS Rev. 2004 Apr-Jun;6(2):67-78.
PubMed 15332429Semprini AE, Fiore S. HIV and pregnancy: is the outlook for mother and baby transformed? Curr Opin Obstet Gynecol. 2004 Dec;16(6):471-5. doi: 10.1097/00001703-200412000-00006.
PubMed 15534442Sullivan JL. Prevention of mother-to-child transmission of HIV--what next? J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S67-72. doi: 10.1097/00126334-200309011-00010.
PubMed 14562860
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Toxicity Among Infants Born to HIV-1-Infected Women Enrolled in Antiretroviral Treatment Protocols in Diverse Areas of the World
- ClinicalTrials.gov ID
- NCT00100867
- Acronym / sponsor ID
- ACTG A5190-P1054
- Conditions
- HIV Infections
- Keywords
- Perinatal Transmission, Mother-to-Child Transmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jun 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 7 Jan 2005 (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.
In clinical trials being conducted throughout the world, pregnant HIV-infected women are given anti-HIV drugs before, during, and after they give birth to prevent mother-to-child transmission of HIV. However, the effects of this anti-HIV treatment on infants is unknown. The purpose of this study is to determine the safety, toxicity, and potential side effects of maternal anti-HIV treatment on infants born to these HIV-infected women.
Study hypothesis: Specific combination antiretroviral regimens used in clinical trials in diverse areas of the world are safe and well tolerated during pregnancy and breastfeeding periods, and are not associated with adverse side effects to the fetus, neonate, and/or breastfeeding infant. These regimens are associated with reduction of mother-to-child HIV transmission.
Detailed description
Many HIV-infected women outside the United States enroll in clinical trials that provide them antiretroviral therapy (ART) to prevent mother-to-child transmission of HIV. However, data are limited on the safety, toxicity, and adverse effects that maternal ART may have on infants born to HIV-infected women. This study will monitor the adverse effects and potential benefits of maternal ART on these infants.
No antiretrovirals will be given in this study. This study will last 18 months. Infants will be enrolled in the study within 48 hours of birth. There will be 6 study visits starting at study entry and every 6 weeks thereafter. Infants will undergo blood and urine collection, and medical history assessments will occur at every visit. Mothers will also be evaluated at these visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants born to HIV-infected women
Key inclusion criteria (2 listed)
- Infant born to HIV-1 infected mother enrolled in NIH-sponsored, international antiretroviral treatment trial AND who has had either in utero or postpartum antiretroviral exposure
- Parent or guardian willing to provide informed consent
Key exclusion criteria (1 listed)
- Infant with no exposure to antiretrovirals OR who received only intrapartum antiretroviral exposure
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
Not reported in the source record.
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 1 Apr 2016.
- Background: PubMed 15595430Abrams EJ. Prevention of mother-to-child transmission of HIV--successes, controversies and critical questions. AIDS Rev. 2004 Jul-Sep;6(3):131-43.
- Background: PubMed 15332429Scarlatti G. Mother-to-child transmission of HIV-1: advances and controversies of the twentieth centuries. AIDS Rev. 2004 Apr-Jun;6(2):67-78.
- Background: PubMed 15534442Semprini AE, Fiore S. HIV and pregnancy: is the outlook for mother and baby transformed? Curr Opin Obstet Gynecol. 2004 Dec;16(6):471-5. doi: 10.1097/00001703-200412000-00006.
- Background: PubMed 14562860Sullivan JL. Prevention of mother-to-child transmission of HIV--what next? J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S67-72. doi: 10.1097/00126334-200309011-00010.
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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.
Karin Nielsen, MD, MPH study chair
University of California, Los Angeles
Judith S. Currier, MD, MSc study chair
Center for AIDS Research and Education, University of California, Los Angeles
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 23 sites in 8 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 2 inclusion and 1 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 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Thailand, India, Brazil, Botswana, Malawi and 3 more countries. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00100867, which also lists 4 linked publications.
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 1 Apr 2016.