OBJECTIVE: To assess patterns of HIV disease progression among HIV-1-infected women following delivery. METHODS: Four hundred ninety-seven women enrolled in PACTG 185, a phase 3 trial of passive immunoprophylaxis in addition tozidovudine (ZDV) for the prevention of perinatal transmission, were included. Visits occurred twice during pregnancy; at delivery; and at 12, 26, 48, and 78 weeks postpartum. Repeated-measures linear regression and proportional hazards models were applied. RESULTS: Trial treatment (HIV hyperimmune globulin vs. immune globulin) was not related to postpartum disease progression. Longitudinal analysis of HIV-1 RNA demonstrated stable levels during pregnancy, significantly increased HIV-1 RNA by 12 weeks postpartum even on stable therapy, and a gradual increase thereafter. Changes in CD4+ lymphocyte percentage over 18 months of follow-up were similar for women continuing or stopping ZDV postpartum. Compared with those receiving no therapy, the hazard ratio for AIDS or death among women who received monotherapy postpartum was 0.52 (95% confidence interval [CI]: 0.25-1.04), 0.17 (CI: 0.06-0.49) for women who received combination therapy, and 0.24 (CI: 0.06-1.01) for women who received highly active antiretroviral therapy. CONCLUSIONS:RNA levels increased significantly from delivery to 12 weeks postpartum. Changes in HIV-1 RNA and CD4+ lymphocyte percentage were similar among women continuing or stopping therapy after delivery, and response to antiretroviral therapy was as expected postpartum.
RCT Entities:
OBJECTIVE: To assess patterns of HIV disease progression among HIV-1-infectedwomen following delivery. METHODS: Four hundred ninety-seven women enrolled in PACTG 185, a phase 3 trial of passive immunoprophylaxis in addition to zidovudine (ZDV) for the prevention of perinatal transmission, were included. Visits occurred twice during pregnancy; at delivery; and at 12, 26, 48, and 78 weeks postpartum. Repeated-measures linear regression and proportional hazards models were applied. RESULTS: Trial treatment (HIV hyperimmune globulin vs. immune globulin) was not related to postpartum disease progression. Longitudinal analysis of HIV-1 RNA demonstrated stable levels during pregnancy, significantly increased HIV-1 RNA by 12 weeks postpartum even on stable therapy, and a gradual increase thereafter. Changes in CD4+ lymphocyte percentage over 18 months of follow-up were similar for women continuing or stopping ZDV postpartum. Compared with those receiving no therapy, the hazard ratio for AIDS or death among women who received monotherapy postpartum was 0.52 (95% confidence interval [CI]: 0.25-1.04), 0.17 (CI: 0.06-0.49) for women who received combination therapy, and 0.24 (CI: 0.06-1.01) for women who received highly active antiretroviral therapy. CONCLUSIONS: RNA levels increased significantly from delivery to 12 weeks postpartum. Changes in HIV-1 RNA and CD4+ lymphocyte percentage were similar among women continuing or stopping therapy after delivery, and response to antiretroviral therapy was as expected postpartum.
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