If there is a negative culture and focal consolidation, and empiric antibiotic therapy is used with no response after 5 days, a BAL is done
If there is a negative culture and focal consolidation, and empiric antibiotic therapy is used with no response after 5 days, a BAL is done. 3-year cumulative mortality rate was 24.9%. The findings will be relevant to clinical and epidemiologic aspects of HIV infection in children. by cardiologic methods and postnatally by sensitive cardiologic and pulmonary surveillance before they become clinically evident To determine whether immunologic dysfunction or co-infections (acquired before or after birth) in patients with vertically transmitted HIV infection lead to progressive pulmonary and/or cardiovascular disease Time Table During the initial 1-year design phase, the study protocol, manual of operations, data collection forms, and distributed data entry system were developed, and training sessions were held. Recruitment began in May 1990 and continued through January 1994. The cohort is being followed for an additional 3 years beyond the end of recruitment; follow-up times will range from 2.5 to 6.6 years. An analysis phase encompasses the DB04760 final 6 months of the study, through July 1997. STUDY POPULATION The cohort DB04760 of subjects being studied includes two groups. Group I is composed of infants and children with documented vertically transmitted HIV infection. Children in Group I must have been born after April 1, 1985, except where vertical transmission of HIV infection can be documented with reasonable medical certainty, and be more than 28 days old. Vertical transmission to the child is defined by HIV infection in the mother or maternal death due to AIDS where there is no evidence of sexual abuse of the child. Children in Group I who were classified as P-2, subclass E (secondary cancers) at enrollment by the 1987 Revised Center for Disease Control (CDC) Classification System [9], as well as children in either group for whom informed consent could not be obtained, were excluded. Group II is composed of infants born to HIV-infected mothers, enrolled during gestation or on or before 28 days of age postnatally. Children in Group II who are later determined to be infected with HIV CLG4B are designated as Group IIa, and uninfected children in Group II are designated Group IIb. The conventional tests for HIV antibody (enzyme-linked immunosorbent assay [ELISA] and Western blot) are used to establish a diagnosis of HIV infection in pregnant women. HIV cultures are performed on Group II children at birth (not cord blood), and 3 and 6 months postnatally. Two positive cultures are necessary to assign a patient to Group IIa (infected). Two negative cultures, one of which must be when the child is 5 months of age or older, are necessary to assign a patient to Group IIb (noninfected). An ELISA and, if necessary, Western blot are performed on DB04760 all Group IIb patients at a minimum age of 15 months to confirm their HIV-negative status. Sample Size, Recruitment, and Randomization Recruitment goals were 200 DB04760 Group I children and 600 Group II infants and children. The sample size of 200 Group I patients was justified on the basis of precision of estimating pulmonary and cardiovascular complication rates. At the time the original study protocol was written, it was estimated that the transmission rate was 30%. The recruitment goal was changed from 500 to 600 Group II patients in February 1993 when it became apparent that the DB04760 actual transmission rate was 20% or less [10]. A subset of approximately 200 Group IIb children is randomly selected to remain on study as.