A Prospective, Observational Study of HIV-Infected Pregnant Women and Their Infants at Clinical Sites in Latin American and Caribbean Countries
|First Received Date ICMJE||June 19, 2006|
|Last Updated Date||April 21, 2017|
|Start Date ICMJE||July 24, 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00341302 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Secondary Outcome Measure: 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...|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||A Prospective, Observational Study of HIV-Infected Pregnant Women and Their Infants at Clinical Sites in Latin American and Caribbean Countries|
|Official Title ICMJE||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.
Prospective cohort study to describe the characteristics of HIV-infected pregnant women and HIV-exposed, uninfected children followed at participating Latin American sites, and to characterize adverse events during pregnancy and the postpartum period (HIV-infected women) and during childhood (HIV-exposed, uninfected children) according to receipt of/exposure to antiretroviral drug(s) .
The study population is comprised of HIV-infected pregnant women and HIV-exposed infants/children.
HIV-infected Women: The study enrolled HIV-infected pregnant women receiving medical care at participating clinical sites who: 1) plan to deliver at the clinical site; and 2) plan to continue postpartum and routine medical care for up to 5 years at the clinical site or associated outpatient facility.
The Pediatric Cohort consists of HIV-exposed, uninfected children born to enrolled HIV-infected women. They were followed for up to 5 years. (HIV-exposed children ultimately determined to be HIV-infected were offered enrollment in a separate study, if eligible.)
In addition, the NISDI study is using data from a locally conducted, single-site maternal-child health cohort study in Brazil (enrolled HIV-uninfected pregnant women and their HIV-unexposed infants) for NISDI analyses that benefit from making comparisons to healthy controls
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||3554|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
Documentation of HIV infection, defined by any two of the following prior to or during pregnancy:
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 infant followed through six months of age.
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 the study.
Subjects may enroll up to and prior to delivery, including during labor.
EXCLUSION CRITERIA: (HIV-Infected Pregnant Women)
Failure to meet inclusion criteria.
|Ages||up to 50 Years (Child, Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Argentina, Brazil, Peru|
|Removed Location Countries||Bahamas, Jamaica, Mexico, United States|
|NCT Number ICMJE||NCT00341302|
|Other Study ID Numbers ICMJE||999902261
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|Study Sponsor ICMJE||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 16, 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP