Pregnant HIV Positive WomenNCT00341302
A Prospective, Observational Study of HIV-Infected Pregnant Women and Their Infants at Clinical Sites in Latin American and Caribbean Countries
An observational study of Pregnant HIV Positive Women, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 12 sites in 3 countries.
Trial summary
By the end of 1999, it was estimated that 1.2 million children were living with HIV infection. During 1999 alone, 600,000 children were newly infected with HIV, mostly in less-developed countries. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnant HIV Positive Women
- How many people
- 3,554 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 25 Jul 2002to 28 Jul 2020
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV -infected pregnant women and HIV exposed, uninfected children followed at participating Latin American sites@@@@@@
Who may be able to join
- Pregnant women at 22 weeks of gestation or more with documentation of pregnancy, using one or more of the following:
- Urine HCG pregnancy test;
- Serum HCG pregnancy test;
- Positive fetal heart tones by Doppler; or
- Ultrasound.
- Documentation of HIV infection, defined by any two of the following prior to or during pregnancy:
Show all 41Show fewer
- Reactive test for HIV antibody;
- Positive HIV culture;
- Positive HIV DNA PCR;
- Positive neutralizable HIV p24 antigen;
- Positive qualitative HIV RNA;
- Quantitative HIV RNA greater than or equal to 1000 copies/ml; and
- Diagnosis of AIDS-defining clinical condition.
- Willingness and intent to deliver at the participating clinical site and to be followed through six months postpartum at the site or associated outpatient facility.
- Willingness and ability to sign informed consent-Subject must be of an age to provide legal informed consent as defined by the country in which the subject resides.
- Willingness and intent to have children followed for up to 5 years.
- Subjects may be co-enrolled in clinical trials for treatment or prophylaxis of HIV infection, opportunistic infections, or other HIV related problems.
- Subjects may be re-enrolled with subsequent pregnancies during this study. However, if so, their follow-up for the previous pregnancy will be discontinued. Children from each pregnancy will be followed in accordance with the protocol.
- Subjects may enroll up to and prior to delivery, including during labor.
- -HIV-exposed children born to enrolled HIV-infected pregnant women. Children diagnosed with HIV infection will be discontinued from the present protocol and(if eligible) offered enrollment into a concurrent NICHD-funded protocol for HIV-infected children.
- -HIV-exposed, uninfected children who are 6 months of age through 5 years 364 days of age and were previously enrolled in the NISDI Pediatric Protocol or NISDI Perinatal Protocol.
- And
- Other HIV-exposed, uninfected children who are 6 months of age through 5 years 364 days of age at time of enrollment into this protocol.
- Documentation of HIV-uninfected status should be obtained from medical
- record review.
- Evidence of the HIV-uninfected status of the infants and children can be documented by the following:
- --Two or more negative HIV virologic assays (e.g., HIV culture or HIV DNA PCR) with one test performed at age 1 month or older and one performed at age 4 months or older, and no positive virologic tests.
- Or
- --One or more negative HIV virologic assays performed at 1 month of age or older with one or more negative HIV antibody tests (including HIV rapid tests) performed at greater than or equal to 6 months of age.
- Or
- --One positive HIV virologic assay, with at least two later negative HIV virologic tests (at least one of which is after age 4 months of age) or negative HIV antibody tests (at least one of which is after 6 months of age).
- Documentation of HIV infection in the mother must have been obtained either prior to or during pregnancy or within one month postpartum.
- Evidence of HIV infection in the mother can be documented by two or more of the following:
- Reactive test for HIV antibody;
- Positive HIV culture;
- Positive HIV DNA PCR;
- Positive quantitative HIV p24 antigen above assay cutoff;
- Positive qualitative HIV RNA;
- Quantitative HIV RNA >= 1000 copies/ml; and
- Diagnosis of AIDS-defining clinical condition.
- Complete data regarding maternal medications received during pregnancy must be available through medical record abstraction.
Who cannot join
- Failure to meet inclusion criteria.
- Failure to meet inclusion criteria
- HIV infection of the child
- Insufficient documentation of HIV infection in the mother obtained either prior to or during pregnancy or within one month postpartum.
- Insufficient evidence of HIV infection in the mother
- Insufficient perinatal data
- Incomplete data regarding maternal medications received during pregnancy (e.g., missing start and stop dates).
- Incomplete data regarding postnatal ARV exposure.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Brazil10 sites
Universidade de Caxias do Sul
Caxias do Sul
Universidade Federal de Minas Gerais
Minas Gerais
Hospital Geral Nova de Iguacu Setor De DST/AIDS
Nova Iguaçu
Hospital Conceicao
Porto Alegre
Hospital Femina
Porto Alegre
Irmandade Da Santa Casa de Misericordia de
Porto Alegre
Hospital dos Servidores do Estado - RJ
Rio de Janeiro
Instituto de Puericultura e Pediatria
Rio de Janeiro
Federal University of Sao Paulo-Escola Paulista de Medicina
São Paulo
Hospital das Clinicas da Falculdade De Medinica
São Paulo
Argentina1 site
Hospital General de Agudos "Jose Maria Ramos Mejia"
Buenos Aires
About this study
Official title: A Prospective, Observational Study of HIV-Infected Pregnant Women and HIV-Exposed, Uninfected Children at Clinical Sites in Latin American Countries
By the end of 1999, it was estimated that 1.2 million children were living with HIV infection. During 1999 alone, 600,000 children were newly infected with HIV, mostly in less-developed countries. Most HIV-infected children are infected by transmission from mother to child during pregnancy, at birth, or through breast milk. Antiretroviral medications, cesarean section before rupture of membranes, and avoidance of breastfeeding are ways to reduce the risk of transmission. This study will determine mother-to-child transmission rates and the effects on infants of exposure to antiretroviral medications and mode of delivery.
Approximately 180 to 240 HIV-infected pregnant women in Mexico and Argentina will be enrolled during the first year of this 5-year study. HIV-infected women will be evaluated during pregnancy, during delivery, and 6 months after delivery. At each visit, a history will be taken and physical examination given; blood will be collected for laboratory tests.
HIV-exposed infants will be evaluated through 6 months of age. At each of 2 visits, a history will be taken and physical examination given; blood will be collected for laboratory tests; and growth will be assessed.
Read the detailed description
This is an observational, prospective cohort study to describe the characteristics of HIV-infected pregnant women and HIV-exposed, uninfected children at participating clinical sites in Latin America where the following are available: 1) antiretrovirals (ARVs) for treatment of HIV-infected women and for prevention of mother-to-child transmission (MTCT) of HIV; and 2) infant formula. We will describe the utilization of interventions related to decreasing the risk of MTCT, including ARV prophylaxis, cesarean section before labor and before ruptured membranes, and complete avoidance of breastfeeding. We will describe receipt of maternal ARV regimens and determine rates of MTCT of HIV. This study will describe maternal adverse events during pregnancy and the postpartum period. In addition, the study will describe child outcomes potentially related to in utero and early postnatal exposure to ARVs. HIV-infected women will be evaluated antepartum, intrapartum, 6 months postpartum and then every 6 months for up to 5 years after delivery. HIV-exposed, uninfected children will be evaluated for up to 5 years of follow-up.
- Conditions
- Pregnant HIV Positive Women
- Keywords
- HIV, AIDS, Perinatal, Transmission, Outcomes
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | HIV Infected Pregnant Women | |
| Pediatric Cohort 2 | HIV exposed , uninfected children born to HIV infected women | |
| Pediatric Cohort 3 | HIV exposed, uninfected children 6 months to 5 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the characteristics of HIV-infected pregnant women and their HIV-exposed children in Latin America, including the rates of and risk factors for mother-to-child transmission
To describe the characteristics of HIV-infected pregnant women and their HIV-exposed children in Latin America, including the rates of and risk factors for mother-to-child transmission.
Measured: in utero, six weeks
To characterize adverse events according to receipt of and exposure to ARVs (by HIV- infected women during pregnancy and postpartum and by their HIV-exposed but uninfected children in utero and during the first few week
To characterize adverse events according to receipt of and exposure to ARVs (by HIV- infected women during pregnancy and postpartum and by their HIV-exposed but uninfected children in utero and during the first few week
Measured: in utero, six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start25 Jul 2002
- Primary completion30 Nov 2011
- Study completion28 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnant HIV Positive WomenStudies 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
- 3,554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nahida A Chakhtoura, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341302
- Sponsor's protocol ID
- 999902261
- Other IDs
- 02-CH-N261
- Status last verified
- Jul 2020
- First submitted
- 19 Jun 2006
- Last updated
- 30 Jul 2020
- Results posted
- No
Publications
Rates of mother-to-child transmission of HIV-1 in Africa, America, and Europe: results from 13 perinatal studies. The Working Group on Mother-To-Child Transmission of HIV. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Apr 15;8(5):506-10. doi: 10.1097/00042560-199504120-00011.
PubMed 7697448U.S. Public Health Service recommendations for human immunodeficiency virus counseling and voluntary testing for pregnant women. MMWR Recomm Rep. 1995 Jul 7;44(RR-7):1-15.
PubMed 7565546Connor EM, Sperling RS, Gelber R, Kiselev P, Scott G, O'Sullivan MJ, VanDyke R, Bey M, Shearer W, Jacobson RL, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994 Nov 3;331(18):1173-80. doi: 10.1056/NEJM199411033311801.
PubMed 7935654
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study of HIV-Infected Pregnant Women and HIV-Exposed, Uninfected Children at Clinical Sites in Latin American Countries
- ClinicalTrials.gov ID
- NCT00341302
- Acronym / sponsor ID
- 999902261
- Conditions
- Pregnant HIV Positive Women
- Keywords
- HIV, AIDS, Perinatal, Transmission, Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,554 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 25 Jul 2002 (actual)
- Primary completion
- 30 Nov 2011 (actual)
- Study completion
- 28 Jul 2020 (actual)
- First posted
- 21 Jun 2006 (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.
By the end of 1999, it was estimated that 1.2 million children were living with HIV infection. During 1999 alone, 600,000 children were newly infected with HIV, mostly in less-developed countries. Most HIV-infected children are infected by transmission from mother to child during pregnancy, at birth, or through breast milk. Antiretroviral medications, cesarean section before rupture of membranes, and avoidance of breastfeeding are ways to reduce the risk of transmission. This study will determine mother-to-child transmission rates and the effects on infants of exposure to antiretroviral medications and mode of delivery.
Approximately 180 to 240 HIV-infected pregnant women in Mexico and Argentina will be enrolled during the first year of this 5-year study. HIV-infected women will be evaluated during pregnancy, during delivery, and 6 months after delivery. At each visit, a history will be taken and physical examination given; blood will be collected for laboratory tests.
HIV-exposed infants will be evaluated through 6 months of age. At each of 2 visits, a history will be taken and physical examination given; blood will be collected for laboratory tests; and growth will be assessed.
Detailed description
This is an observational, prospective cohort study to describe the characteristics of HIV-infected pregnant women and HIV-exposed, uninfected children at participating clinical sites in Latin America where the following are available: 1) antiretrovirals (ARVs) for treatment of HIV-infected women and for prevention of mother-to-child transmission (MTCT) of HIV; and 2) infant formula. We will describe the utilization of interventions related to decreasing the risk of MTCT, including ARV prophylaxis, cesarean section before labor and before ruptured membranes, and complete avoidance of breastfeeding. We will describe receipt of maternal ARV regimens and determine rates of MTCT of HIV. This study will describe maternal adverse events during pregnancy and the postpartum period. In addition, the study will describe child outcomes potentially related to in utero and early postnatal exposure to ARVs. HIV-infected women will be evaluated antepartum, intrapartum, 6 months postpartum and then every 6 months for up to 5 years after delivery. HIV-exposed, uninfected children will be evaluated for up to 5 years of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –HIV Infected Pregnant Women |
| Pediatric Cohort 2 | – | –HIV exposed , uninfected children born to HIV infected women |
| Pediatric Cohort 3 | – | –HIV exposed, uninfected children 6 months to 5 years of age |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV -infected pregnant women and HIV exposed, uninfected children followed at participating Latin American sites@@@@@@
Key inclusion criteria (41 listed)
- Pregnant women at 22 weeks of gestation or more with documentation of pregnancy, using one or more of the following:
- Urine HCG pregnancy test;
- Serum HCG pregnancy test;
- Positive fetal heart tones by Doppler; or
- Ultrasound.
Key exclusion criteria (8 listed)
- Failure to meet inclusion criteria.
- Failure to meet inclusion criteria
- HIV infection of the child
- Insufficient documentation of HIV infection in the mother obtained either prior to or during pregnancy or within one month postpartum.
- Insufficient evidence of HIV infection in the mother
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
To describe the characteristics of HIV-infected pregnant women and their HIV-exposed children in Latin America, including the rates of and risk factors for mother-to-child transmission
Time frame: in utero, six weeks
To describe the characteristics of HIV-infected pregnant women and their HIV-exposed children in Latin America, including the rates of and risk factors for mother-to-child transmission.
To characterize adverse events according to receipt of and exposure to ARVs (by HIV- infected women during pregnancy and postpartum and by their HIV-exposed but uninfected children in utero and during the first few week
Time frame: in utero, six weeks
To characterize adverse events according to receipt of and exposure to ARVs (by HIV- infected women during pregnancy and postpartum and by their HIV-exposed but uninfected children in utero and during the first few week
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 30 Jul 2020.
- Background: PubMed 7697448Rates of mother-to-child transmission of HIV-1 in Africa, America, and Europe: results from 13 perinatal studies. The Working Group on Mother-To-Child Transmission of HIV. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Apr 15;8(5):506-10. doi: 10.1097/00042560-199504120-00011.
- Background: PubMed 7565546U.S. Public Health Service recommendations for human immunodeficiency virus counseling and voluntary testing for pregnant women. MMWR Recomm Rep. 1995 Jul 7;44(RR-7):1-15.
- Background: PubMed 7935654Connor EM, Sperling RS, Gelber R, Kiselev P, Scott G, O'Sullivan MJ, VanDyke R, Bey M, Shearer W, Jacobson RL, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994 Nov 3;331(18):1173-80. doi: 10.1056/NEJM199411033311801.
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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.
Nahida A Chakhtoura, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant HIV Positive Women, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 12 sites in 3 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 41 inclusion and 8 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 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Brazil, Argentina, Peru. 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?
To describe the characteristics of HIV-infected pregnant women and their HIV-exposed children in Latin America, including the rates of and risk factors for mother-to-child transmission (time frame: in utero, six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341302, which also lists 3 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 30 Jul 2020.