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J Neurovirol. 2016 Feb;22(1):104-13. doi: 10.1007/s13365-015-0374-7. Epub 2015 Aug 25.

Peripheral neuropathy in HIV patients in sub-Saharan Africa failing first-line therapy and the response to second-line ART in the EARNEST trial.

Collaborators (265)

Agweng E, Awio P, Bakeinyaga G, Isabirye C, Kabuga U, Kasuswa S, Katuramu M, Kityo C, Kiweewa F, Kyomugisha H, Lutalo E, Mugyenyi P, Mulima D, Musana H, Musitwa G, Musiime V, Ndigendawan M, Namata H, Nkalubo J, Ocitti Labejja P, Okello P, Olal P, Pimundu G, Segonga P, Ssali F, Tamale Z, Tumukunde D, Namala W, Byaruhanga R, Kayiwa J, Tukamushaba J, Bihabwa G, Buluma E, Easterbrook P, Elbireer A, Kambugu A, Kamya D, Katwere M, Kiggundu R, Komujuni C, Laker E, Lubwama E, Mambule I, Matovu J, Nakajubi A, Nakku J, Nalumenya R, Namuyimbwa L, Semitala F, Wandera B, Wanyama J, Mugerwa H, Lugemwa A, Ninsiima E, Ssenkindu T, Mwebe S, Atwine L, William H, Katemba C, Abunyang S, Acaku M, Ssebutinde P, Kitizo H, Kukundakwe J, Naluguza M, Ssegawa K, Namayanja, Nsibuka F, Tuhirirwe P, Fortunate M, Acen J, Achidri J, Amone A, Chamai M, Ditai J, Kemigisa M, Kiconco M, Matama C, Mbanza D, Nambaziira F, Owor Odoi M, Rweyora A, Tumwebaze G, Kalanzi H, Katabaazi J, Kiyingi A, Mbidde M, Mugenyi M, Mwebaze R, Okong P, Senoga I, Abwola M, Baliruno D, Bwomezi J, Kasede A, Mudoola M, Namisi R, Ssennono F, Tuhirwe S, Abongomera G, Amone G, Abach J, Aciro I, Arach B, Kidega P, Omongin J, Ocung E, Odong W, Philliam A, Alima H, Ahimbisibwe B, Atuhaire E, Atukunda F, Bekusike G, Bulegyeya A, Kahatano D, Kamukama S, Kyoshabire J, Nassali A, Mbonye A, Naturinda TM, Ndukukire, Nshabohurira A, Ntawiha H, Rogers A, Tibyasa M, Kiirya S, Atwongeire D, Nankya A, Draleku C, Nakiboneka D, Odoch D, Lakidi L, Ruganda R, Abiriga R, Mulindwa M, Balmoi F, Kafuma S, Moriku E, Hakim J, Reid A, Chidziva E, Musoro G, Warambwa C, Tinago G, Mutsai S, Phiri M, Mudzingwa S, Bafana T, Masore V, Moyo C, Nhema R, Chitongo S, Heyderman R, Kabanga L, Kaunda S, Kudzala A, Lifa L, Mallewa J, Moore M, Mtali C, Musowa G, Mwimaniwa G, Sikwese R, van Oosterhout J, Ziwoya M, Chimbaka H, Chitete B, Kamanga S, Makwakwa TK, Mbiya R, Mlenga M, Mphande T, Mtika C, Mushani G, Ndhlovu O, Ngonga M, Nkhana I, Nyirenda R, Cheruiyot P, Kwobah C, Ekiru WL, Mokaya M, Mudogo A, Nzioka A, Siika A, Tanui M, Wachira S, Wools-Kaloustian K, Alipalli P, Chikatula E, Kipaila J, Kunda I, Lakhi S, Malama J, Mufwambi W, Mulenga L, Mwaba P, Mwamba E, Mweemba A, Namfukwe M, Kerukadho E, Ngwatu B, Birungi J, Paton N, Boles J, Burke A, Castle L, Ghuman S, Kendall L, Hoppe A, Tebbs S, Thomason M, Thompson J, Walker S, Whittle J, Wilkes H, Young N, Kapuya C, Kyomuhendo F, Kyakundi D, Mkandawire N, Mulambo S, Senyonjo S, Angus B, Arenas-Pinto A, Palfreeman A, Post F, Ishola D, Arribas J, Colebunders B, Floridia M, Giuliano M, Mallon P, Walsh P, De Rosa M, Rinaldi E, Weller I, Gilks C, Hakim J, Kangewende A, Lakhi S, Luyirika E, Miiro F, Mwamba P, Mugyenyi P, Ojoo S, Paton N, Phiri S, van Oosterhout J, Siika A, Walker S, Wapakabulo A, Peto T, French N, Matenga J, Cloherty G, van Wyk J, Norton M, Lehrman S, Lamba P, Malik K, Rooney J, Snowden W, Villacian J.

Author information

1
MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, Aviation House, 125 Kingsway, London, WC2B 6NH, UK. A.Arenas-Pinto@ucl.ac.uk.
2
MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
3
University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.
4
Joint Clinical Research Centre (JCRC), Kampala, Uganda.
5
Joint Clinical Research Centre (JCRC), Mbarara, Uganda.
6
Infectious Diseases Institute, Makerere University, Kampala, Uganda.
7
University Teaching Hospital, Lusaka, Zambia.
8
Joint Clinical Research Centre (JCRC), Kakira, Uganda.
9
National University of Singapore, Singapore, Singapore.

Abstract

Sensory peripheral neuropathy (PN) remains a common complication in HIV-positive patients despite effective combination anti-retroviral therapy (ART). Data on PN on second-line ART is scarce. We assessed PN using a standard tool in patients failing first-line ART and for 96 weeks following a switch to PI-based second-line ART in a large Randomised Clinical Trial in Sub-Saharan Africa. Factors associated with PN were investigated using logistic regression. Symptomatic PN (SPN) prevalence was 22% at entry (N = 1,251) and was associated (p < 0.05) with older age (OR = 1.04 per year), female gender (OR = 1.64), Tuberculosis (TB; OR = 1.86), smoking (OR = 1.60), higher plasma creatinine (OR = 1.09 per 0.1 mg/dl increase), CD4 count (OR = 0.83 per doubling) and not consuming alcohol (OR = 0.55). SPN prevalence decreased to 17% by week 96 (p = 0.0002) following similar trends in all study groups (p = 0.30). Asymptomatic PN (APN) increased over the same period from 21 to 29% (p = 0.0002). Signs suggestive of PN (regardless of symptoms) returned to baseline levels by week 96. At weeks 48 and 96, after adjusting for time-updated associations above and baseline CD4 count and viral load, SPN was strongly associated with TB (p < 0.0001). In summary, SPN prevalence was significantly reduced with PI-based second-line therapy across all treatment groups, but we did not find any advantage to the NRTI-free regimens. The increase of APN and stability of PN-signs regardless of symptoms suggest an underlying trend of neuropathy progression that may be masked by reduction of symptoms accompanying general health improvement induced by second-line ART. SPN was strongly associated with isoniazid given for TB treatment.

KEYWORDS:

Africa; HIV; Peripheral neuropathy; Second-line ART; Tuberculosis

PMID:
26323809
DOI:
10.1007/s13365-015-0374-7
[Indexed for MEDLINE]

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