| Extended prophylaxis with nevirapine and cotrimoxazole among HIV-exposed uninfected infants is well tolerated. | |
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MedLine Citation:
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PMID: 22112598 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: Nevirapine and cotrimoxazole are associated with hematologic toxicities and skin-rash. Safety of their concurrent use for prophylaxis over extended periods among HIV-exposed uninfected infants has not been previously assessed. DESIGN: Secondary data analysis of the 'HIV Prevention Trials Network-046 protocol' (version 2.0), a phase-III, randomized, placebo-controlled trial that assessed efficacy and safety of nevirapine prophylaxis against breast milk transmission of HIV-1. METHODS: Trial infants received 6-month study nevirapine/placebo, and standard-of-care peripartum single-dose nevirapine+/- zidovudine 'tail', and cotrimoxazole prophylaxis from 6 weeks through breastfeeding cessation. Adverse events were monitored using United States Division of AIDS Toxicity Tables (2004). Risk of neutropenia, anemia and skin-rash in the cotrimoxazole + nevirapine and the cotrimoxazole + placebo groups were compared using negative-binomial regression. RESULTS: Incidence of neutropenia and/or anemia, and skin-rash was highest during the first 6 weeks of life and declined, thereafter, regardless of study group. Time to first adverse event after 6 weeks was similar in cotrimoxazole + nevirapine and cotrimoxazole + placebo groups: hazard ratio (95% confidence interval) was 1.26 (0.96-1.66) for neutropenia and/or anemia (all grades), 1.27 (0.80-2.03) for neutropenia and/or anemia (grade ≥3) and 1.16 (0.46-2.90) for skin-rash (grade ≥2). There were no statistically significant differences in immediate (6 weeks-6 months) and long-term (6-12 months) adverse event risk among infants on cotrimoxazole + nevirapine versus cotrimoxazole + placebo. CONCLUSION: Extended nevirapine and cotrimoxazole prophylaxis through 6 months of age among HIV-exposed uninfected infants did not appear to increase the immediate or long-term risk of neutropenia, anemia or skin-rash. Concurrent use beyond 6 months, however, needs to be evaluated. |
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Authors:
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Jim Aizire; Mary Glenn Fowler; Jing Wang; Avinash K Shetty; Lynda Stranix-Chibanda; Moreen Kamateeka; Elizabeth R Brown; Steve G Bolton; Philippa M Musoke; Hoosen Coovadia |
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Publication Detail:
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Type: Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: AIDS (London, England) Volume: 26 ISSN: 1473-5571 ISO Abbreviation: AIDS Publication Date: 2012 Jan |
Date Detail:
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Created Date: 2012-01-05 Completed Date: 2012-03-21 Revised Date: 2013-03-21 |
Medline Journal Info:
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Nlm Unique ID: 8710219 Medline TA: AIDS Country: England |
Other Details:
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Languages: eng Pagination: 325-33 Citation Subset: IM; X |
Affiliation:
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Makerere University, Johns Hopkins University Research Collaboration, Kampala, Uganda. |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00074412 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Anemia / chemically induced* Anti-HIV Agents / administration & dosage*, adverse effects Blotting, Western Breast Feeding / adverse effects Drug Administration Schedule Drug Eruptions / etiology Exanthema / chemically induced* Female HIV Seropositivity / drug therapy*, epidemiology, transmission HIV-1 / drug effects* Humans Infant Infant, Newborn Infectious Disease Transmission, Vertical / prevention & control* Male Milk, Human / virology Neutropenia / chemically induced* Nevirapine / administration & dosage*, adverse effects Pregnancy Risk Factors Time Factors Treatment Outcome Trimethoprim-Sulfamethoxazole Combination / administration & dosage*, adverse effects Uganda / epidemiology |
| Grant Support | |
ID/Acronym/Agency:
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N01-DK-9-001/HHSN267200800001C/DK/NIDDK NIH HHS; U01 AI068632/AI/NIAID NIH HHS; U01 AI068632-03/AI/NIAID NIH HHS; U01AI46749/AI/NIAID NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Anti-HIV Agents; 129618-40-2/Nevirapine; 8064-90-2/Trimethoprim-Sulfamethoxazole Combination |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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