PROMISE Study to Begin Enrolling Women and Their Infants to Examine Best Ways to Prevent HIV Transmission During Pregnancy and Breastfeeding
"On January 15, a large, multinational clinical trial began to determine how best to reduce the risk of HIV transmission from infected pregnant women to their babies during pregnancy and breastfeeding while preserving the health of these children and their mothers.
“The PROMISE ('Promoting Maternal-Infant Survival Everywhere') study aims to enroll 7,950 HIV-infected women who are pregnant or have recently given birth and 5,950 HIV-exposed infants of these women. …
“The study addresses four distinct research questions. Most volunteers will participate in multiple components of the study to answer these questions. The first component will examine which of two proven strategies is safer and more effective at preventing mother-to-child HIV transmission before and during delivery …
“The second component of the PROMISE study will compare the safety and efficacy of two methods of preventing mother-to-child HIV transmission during breastfeeding. ...
“The third component of the PROMISE study will examine the effects of short-term use of a three-antiretroviral-drug regimen during pregnancy and breastfeeding to prevent mother-to-child HIV transmission on the health of HIV-infected mothers who do not yet need treatment. …
“The last component of the PROMISE study involves protecting the health of HIV-exposed but uninfected infants. …
"In this fourth component of the PROMISE study, nearly 2,290 HIV-exposed but uninfected, weaned infants under one year old will be assigned at random either to continue receiving cotrimoxazole or to receive a placebo through age 18 months."
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Study Suggests New Wave of Antiretroviral-Resistant HIV Could Emerge
“Over the past two decades, HIV resistance to antiretrovirals (ARVs) has risen to high levels in the wealthier countries of the world able to afford widespread treatment. We have gained insights into the evolution and transmission dynamics of ARV resistance by designing a biologically complex multistrain network model. Using this model, we traced the evolutionary history of ARV resistance in San Francisco and predict the future dynamics. Using classification and regression trees, we have identified the key immunologic, virologic, and treatment factors that increase ARV resistance. Our modeling shows that 60% of the currently circulating ARV-resistant strains in San Francisco are capable of causing self-sustaining epidemics, as each individual infected with one of these strains can cause on average more than one new resistant infection. It is possible that a new wave of ARV-resistant strains that pose a significant threat to global public health is emerging.”
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NOCTE Study Examines the Effect of Dosing Schedules and Beliefs About HAART on Adherence
“Participants were randomized to receive once nightly didanosine plus lamivudine, or twice-daily combivir (zidovudine plus lamivudine) both in combination with efavirenz. Medication Event Monitoring Systems were used to compile drug-dosing histories. Beliefs about HAART (necessity and concerns) were measured at baseline using validated questionnaires. Perceptions of HAART intrusiveness were assessed after 4 weeks. … Eighty-seven patients were randomized (44 once-nightly and 43 twice-daily). Overall adherence was higher among the once-nightly arm (P = 0.0327). Eighty-one percent once-nightly and 62% twice-daily patients persisted with treatment for 48 weeks (P = 0.0559). Regimen execution was similar between both arms. Participants were significantly less likely to persist with HAART if their initial concerns about HAART were high relative to their perceived need for treatment (P = 0.025). … The difference in adherence observed between once-nightly and twice-daily dosing was driven by a difference in persistence with treatment. Psychological preparation for starting HAART should address patients' perceptions of necessity for HAART and concerns about adverse effects to maximize persistence with treatment.”
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