Using point-of-care testing to make rapid HIV-1 tests in labor really rapid.
Explore the source record for details and available documents.
Biomedical subjects
Publications and source records attributed to Marc Bulterys.
Explore the source record for details and available documents.
OBJECTIVE: To determine the relationship of maternal health factors and infant antiretroviral treatment to the risk of pediatric disease progression to AIDS or death by 24 months of age. DESIGN: Prospective perinatal HIV-1 transmission and pediatric natural history study. SETTING: Urban medical centers in four cities in the USA. PARTICIPANTS: A total of 2656 pregnant and postpartum HIV-infected women enrolled in the Perinatal AIDS Collaborative Transmission Study (PACTS) and 360 children determined to be HIV-infected. MAIN OUTCOME MEASURES: Pediatric AIDS or death by 24 months of age. RESULTS: Children born to mothers with class C disease, CD4 cell count < 200 x 106/l, or HIV-1 RNA viral load > 100 000 copies/ml progressed more rapidly than children born to mothers with less advanced disease. In a multivariate analysis, there was an increased risk of progression if mothers had Class C disease [relative risk (RR), 1.7; 95% confidence interval (CI), 1.0-2.7] or HIV-1 RNA > 100 000 copies/ml (RR, 2.4; 95% CI, 1.2-4.6) controlling for child antiretroviral therapy and year of birth. Earlier years of birth significantly increased the likelihood of rapid progression (P = 0.01) in this multivariate model. Children who received combination antiretroviral therapies with a protease inhibitor or non-nucleoside reverse transcriptase inhibitor were significantly less likely to progress compared with those receiving no therapy (P = 0.03). CONCLUSIONS: HIV-1-infected infants born to women with advanced HIV-1 disease were at increased risk for rapid disease progression. More recent birth year and early treatment with potent antiretroviral therapy significantly diminished the likelihood of developing AIDS or dying during early childhood.
Quantitative HIV RNA testing was used for diagnosis in 156 HIV-exposed non-breast-fed infants at less than 6 months of age (54 infected, 102 uninfected) enrolled in the Perinatal AIDS Collaborative Transmission Study. Sensitivity was 29% in the first week, 79% at 8 to 28 days of age, and >90% at 29 days of age and thereafter; specificity was 100% in all periods, except at 29 to 60 days of age, when specificity was 93%. Neither sensitivity nor specificity was significantly affected by maternal or infant zidovudine (ZDV) treatment, even though infant viral loads were lower during the first 6 weeks in infants who received perinatal ZDV prophylaxis ( p=.005). Paired analysis of DNA and RNA measurements revealed no advantage for either test. Quantitative RNA testing can be used for diagnosis in HIV-exposed infants, recognizing the chance for a false-positive test result. It may be most useful as a confirmatory test in infants with another positive diagnostic test result.
OBJECTIVE: To estimate the incremental societal costs and effectiveness of a second human immunodeficiency virus (HIV) antibody test during the third trimester of pregnancy compared with no second test. METHODS: We used a decision tree in this cost-effectiveness analysis to model outcomes among pregnant women in high-risk communities and nationwide who received an initial, negative HIV antibody test during the first trimester. The main outcome measure was discounted costs per year of infant life saved. RESULTS: In high-risk communities with estimated HIV incidence of 6.2 per 1000 person-years, a second HIV test compared with no second test would detect 192 infections in women, prevent approximately 37 infant infections, and save 655 infant life-years per 100,000 women tested. Net savings would be 5.2 million US dollars. Applied to an estimated national incidence of.17 per 1000 person-years, a second test would detect 5.3 infections in women, prevent 1.3 infant infections, and save 23.3 infant life-years per 100,000 women tested. Net costs would be 1.06 million US dollars, or 45,708 US dollars for each year of infant life saved. A second test would result in net savings in populations with HIV incidence of 1.2 per 1000 person-years or higher. CONCLUSION: Health care providers serving women in communities with an HIV incidence of 1 per 1000 person-years or higher should strongly consider implementing a second voluntary universal HIV test during the third trimester. Providers serving lower-risk communities should pilot second testing to assess community-specific costs.
BACKGROUND: Although increasing attention has been focused on the adequacy of the informed consent process for participation in research studies, there has been little systematic evaluation of the process, particularly when consent is obtained in the labor and delivery setting. The Mother Infant Rapid Intervention at Delivery (MIRIAD) study is an ongoing multisite study initiated by the Centers for Disease Control and Prevention (CDC) designed to evaluate the feasibility of offering 24-hour counseling and voluntary rapid HIV testing and antriretroviral therapy when indicated to women with unknown HIV status who are in labor. METHODS: To address concerns about obtaining informed consent from women in labor, we have completed focus groups, conducted a pilot of the informed consent process among women in labor, developed flip-charts to enhance comprehension, and plan an ongoing evaluation of the informed consent process throughout the course of the MIRIAD study. RESULTS: In the pilot study, approximately 70% of women were able to state in their own words the purpose and benefits of the research study. Substantially fewer women (25%) were able to state one or more risks of the study. CONCLUSIONS: We hope that the MIRIAD study will make a valuable contribution by defining best approaches for informed consent and will provide guidance when it is necessary to obtain consent from laboring women for crucial interventions.
BACKGROUND: Some studies suggest that combination antiretroviral therapy in pregnant women with human immunodeficiency virus type 1 (HIV-1) infection increases the risk of premature birth and other adverse outcomes of pregnancy. METHODS: We studied pregnant women with HIV-1 infection who were enrolled in seven clinical studies and delivered their infants from 1990 through 1998. The cohort comprised 2123 women who received antiretroviral therapy during pregnancy (monotherapy in 1590, combination therapy without protease inhibitors in 396, and combination therapy with protease inhibitors in 137) and 1143 women who did not receive antiretroviral therapy. RESULTS: After standardization for the CD4+ cell count and use or nonuse of tobacco, alcohol, and illicit drugs, the rate of premature delivery (<37 weeks of gestation) was similar among the women who received antiretroviral therapy and those who did not (16 percent and 17 percent, respectively); the rate of low birth weight (<2500 g) was 16 percent among the infants born to both groups; and the rate of very low birth weight (<1500 g) was 2 percent for the group that received antiretroviral therapy and 1 percent for the group that did not. The rates of low Apgar scores (<7) and stillbirth were also similar or the same in the two groups. After adjustment for multiple risk factors, combination antiretroviral therapy was not associated with an increased risk of premature delivery as compared with monotherapy (odds ratio, 1.08; 95 percent confidence interval, 0.71 to 1.62) or delivery of an infant with low birth weight (odds ratio, 1.03; 95 percent confidence interval, 0.64 to 1.63). Seven of the women who received combination therapy with protease inhibitors (5 percent) had infants with very low birth weight, as compared with nine women who received combination therapy without protease inhibitors (2 percent) (adjusted odds ratio, 3.56; 95 percent confidence interval, 1.04 to 12.19). CONCLUSIONS: As compared with no antiretroviral therapy or monotherapy, combination therapy for HIV-1 infection in pregnant women is not associated with increased rates of premature delivery or with low birth weight, low Apgar scores, or stillbirth in their infants. The association between combination therapy with protease inhibitors and an increased risk of very low birth weight requires confirmation.
Explore the source record for details and available documents.