A Prospective, Observational Study of HIV-Infected Pregnant Women and Their Infants at Clinical Sites in Latin American and Caribbean Countries

Inclusion Criteria

• •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:
• •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.
• •1. Documentation of HIV-uninfected status should be obtained from medical
• •record review.
• •2. 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).
• •3. Documentation of HIV infection in the mother must have been obtained either prior to or during pregnancy or within one month postpartum.
• •4. 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.
• •5. Complete data regarding maternal medications received during pregnancy must be available through medical record abstraction.