Document Detail

Extended prophylaxis with nevirapine and cotrimoxazole among HIV-exposed uninfected infants is well tolerated.
MedLine Citation:
PMID:  22112598     Owner:  NLM     Status:  MEDLINE    
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.
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:
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:
Title:  AIDS (London, England)     Volume:  26     ISSN:  1473-5571     ISO Abbreviation:  AIDS     Publication Date:  2012 Jan 
Date Detail:
Created Date:  2012-01-05     Completed Date:  2012-03-21     Revised Date:  2013-06-27    
Medline Journal Info:
Nlm Unique ID:  8710219     Medline TA:  AIDS     Country:  England    
Other Details:
Languages:  eng     Pagination:  325-33     Citation Subset:  IM; X    
Makerere University, Johns Hopkins University Research Collaboration, Kampala, Uganda.
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MeSH Terms
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*
HIV Seropositivity / drug therapy*,  epidemiology,  transmission
HIV-1 / drug effects*
Infant, Newborn
Infectious Disease Transmission, Vertical / prevention & control*
Milk, Human / virology
Neutropenia / chemically induced*
Nevirapine / administration & dosage*,  adverse effects
Risk Factors
Time Factors
Treatment Outcome
Trimethoprim-Sulfamethoxazole Combination / administration & dosage*,  adverse effects
Uganda / epidemiology
Grant Support
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
Reg. No./Substance:
0/Anti-HIV Agents; 129618-40-2/Nevirapine; 8064-90-2/Trimethoprim-Sulfamethoxazole Combination

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