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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Fixed duration interruptions are inferior to continuous treatment in African adults starting therapy with CD4 cell counts < 200 cells/μl
AIDS, Volume 22, No. 2, Year 2008
Notification
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Description
BACKGROUND: Structured treatment interruption (STI) of antiretroviral therapy (ART) could potentially reduce cost and toxicity, but clinical efficacy requires evaluation. METHODS: An assessment of fixed-duration STI was nested in DART, a multicentre trial comparing strategies for monitoring ART in Uganda and Zimbabwe (ISCRTN 13968779). Of 3316 ART-naive symptomatic adults with CD4 cell count < 200 cells/μl at ART initiation, 813 with ≥ 300 cells/μl after 48 or 72 weeks underwent a second randomization to either STI, cycles of 12 weeks on/off (408), or continuous ART (CT; 405). RESULTS: Median age at STI/CT randomization was 37 years (range, 19-67) and CD4 cell count 358 cells/μl (range, 300-1054). A second review terminated the STI/CT randomisation on 15 March 2006, and participants changed to CT. Median follow-up was 51 weeks (range, 0-85): 99% and 50% of time was spent on ART in CT and STI, respectively. First new World Health Organization (WHO) stage 4 events or death occurred more frequently in STI (24; 6.4/100 person-years) than CT (9; 2.4/100 person-years) (hazard ratio, 2.73; 95% confidence interval, 1.27-5.88; P = 0.007); oesophageal candidiasis being the most frequent event (STI, 13; CT, 3). Nine (1%) participants died (STI, 5; CT, 4). There was no difference in time to first serious adverse event (P = 0.78), although ART change owing to toxicity occurred more with CT (10; 2.6/100 person-years) than with STI (2; 0.5/100 person-years) (P = 0.02). CONCLUSIONS: Although absolute rates of WHO stage 4 events/death were low, 12 week STIS initiated at a CD4 cell count ≥ 300 cells/μl resulted in a greater than twofold increased relative rate of disease progression compared with continuous therapy in adult Africans initiating ART with advanced disease, and cannot be recommended. © 2008 Lippincott Williams & Wilkins, Inc.
Authors & Co-Authors
Latif, Ahamed S.
Zimbabwe, Harare
University of Zimbabwe
Hakim, James Gita
Zimbabwe, Harare
University of Zimbabwe
Robertson, Valerie J.
Zimbabwe, Harare
University of Zimbabwe
Reid, Andrew
Zimbabwe, Harare
University of Zimbabwe
Bulaya-Tembo, Ruth
Zimbabwe, Harare
University of Zimbabwe
Chimbetete, Cleophas
Zimbabwe, Harare
University of Zimbabwe
Jamu, A.
Zimbabwe, Harare
University of Zimbabwe
Makota, S.
Zimbabwe, Harare
University of Zimbabwe
Mupudzi, T.
Zimbabwe, Harare
University of Zimbabwe
Musoro, Godfrey
Zimbabwe, Harare
University of Zimbabwe
Ngorima, Nicoletta
Zimbabwe, Harare
University of Zimbabwe
Pascoe, Margaret J.
Zimbabwe, Harare
University of Zimbabwe
Taziwa, Fabian
Zimbabwe, Harare
University of Zimbabwe
Warambwa, Colin
Zimbabwe, Harare
University of Zimbabwe
Chidziva, Ennie
Zimbabwe, Harare
University of Zimbabwe
Chigwedere, Edward
Zimbabwe, Harare
University of Zimbabwe
Phiri, Misheck Nkalo
Zimbabwe, Harare
University of Zimbabwe
Chakonza, L.
Zimbabwe, Harare
University of Zimbabwe
Tinago, Gloria C.
Zimbabwe, Harare
University of Zimbabwe
Chirairo, H.
Zimbabwe, Harare
University of Zimbabwe
Chitsungo, S.
Zimbabwe, Harare
University of Zimbabwe
Mapinge, F.
Zimbabwe, Harare
University of Zimbabwe
Mawora, A.
Zimbabwe, Harare
University of Zimbabwe
Muvirimi, C.
Zimbabwe, Harare
University of Zimbabwe
Shoniwa, R.
Zimbabwe, Harare
University of Zimbabwe
Zengeza, G. E.
Zimbabwe, Harare
University of Zimbabwe
Chimanzi, Joy
Zimbabwe, Harare
University of Zimbabwe
Machingura, J.
Zimbabwe, Harare
University of Zimbabwe
Maweni, C.
Zimbabwe, Harare
University of Zimbabwe
Mutsai, Shirley
Zimbabwe, Harare
University of Zimbabwe
Warara, R.
Zimbabwe, Harare
University of Zimbabwe
Matongo, M.
Zimbabwe, Harare
University of Zimbabwe
Bafana, Themelihle
Zimbabwe, Harare
University of Zimbabwe
Mdege, N. D.
Zimbabwe, Harare
University of Zimbabwe
Mudzingwa, Shepherd
Zimbabwe, Harare
University of Zimbabwe
Jangano, Maureen
Zimbabwe, Harare
University of Zimbabwe
Machingura, Ian
Zimbabwe, Harare
University of Zimbabwe
Moyo, Kundai
Zimbabwe, Harare
University of Zimbabwe
Tsiga, C.
Zimbabwe, Harare
University of Zimbabwe
Vere, L.
Zimbabwe, Harare
University of Zimbabwe
Chitongo, Stuart
Zimbabwe, Harare
University of Zimbabwe
Manyevere, K.
Zimbabwe, Harare
University of Zimbabwe
Chivige, E.
Zimbabwe, Harare
University of Zimbabwe
Mugyenyi, Peter N.
Uganda, Kampala
Joint Clinical Research Center Uganda
Kityo, Cissy Mutuluuza
Uganda, Kampala
Joint Clinical Research Center Uganda
Tumukunde, Dinah
Uganda, Kampala
Joint Clinical Research Center Uganda
Ssali, Francis N.
Uganda, Kampala
Joint Clinical Research Center Uganda
Atwine, Diana
Uganda, Kampala
Joint Clinical Research Center Uganda
Mulindwa, Gertrude Kayaga
Uganda, Kampala
Joint Clinical Research Center Uganda
Kabuye, Geoffrey
Uganda, Kampala
Joint Clinical Research Center Uganda
Uganda, Entebbe
Uganda Virus Research Institute
Byaruhanga, Rose
Uganda, Kampala
Joint Clinical Research Center Uganda
Bakeimyaga-Grace, T.
Uganda, Kampala
Joint Clinical Research Center Uganda
Katabira, H.
Uganda, Kampala
Joint Clinical Research Center Uganda
Nimwesiga, E.
Uganda, Kampala
Joint Clinical Research Center Uganda
Barungi, G.
Uganda, Kampala
Joint Clinical Research Center Uganda
Atwiine, Simon Peter
Uganda, Kampala
Joint Clinical Research Center Uganda
Ahimbisibwe, Fred
Uganda, Kampala
Joint Clinical Research Center Uganda
Tugume, Sitefano Buguruka
Uganda, Kampala
Joint Clinical Research Center Uganda
Otim, T.
Uganda, Kampala
Joint Clinical Research Center Uganda
Takubwa, J.
Uganda, Kampala
Joint Clinical Research Center Uganda
Mulindwa, M.
Uganda, Kampala
Joint Clinical Research Center Uganda
Murungi, S.
Uganda, Kampala
Joint Clinical Research Center Uganda
Tukamushaba, J.
Uganda, Kampala
Joint Clinical Research Center Uganda
Muebesa, D.
Uganda, Kampala
Joint Clinical Research Center Uganda
Kyomugisha, Hope
Uganda, Kampala
Joint Clinical Research Center Uganda
Kagina, J.
Uganda, Kampala
Joint Clinical Research Center Uganda
Namale, Letitia
Uganda, Kampala
Joint Clinical Research Center Uganda
Grosskurth, Heiner
Uganda, Entebbe
Uganda Virus Research Institute
Munderi, Paula
Uganda, Entebbe
Uganda Virus Research Institute
Wangati, K.
Uganda, Entebbe
Uganda Virus Research Institute
Ruberantwari, Anthony
Uganda, Entebbe
Uganda Virus Research Institute
Amuron, Barbara
Uganda, Entebbe
Uganda Virus Research Institute
Nsibambi, D.
Uganda, Entebbe
Uganda Virus Research Institute
Kasirye, Ronnie P.
Uganda, Entebbe
Uganda Virus Research Institute
Zalwango, Eva
Uganda, Entebbe
Uganda Virus Research Institute
Nakazibwe, M.
Uganda, Entebbe
Uganda Virus Research Institute
Kikaire, Bernard
Uganda, Entebbe
Uganda Virus Research Institute
Nassuna, Gladys
Uganda, Entebbe
Uganda Virus Research Institute
Massa, Rosemary
Uganda, Entebbe
Uganda Virus Research Institute
Aber, M.
Uganda, Entebbe
Uganda Virus Research Institute
Namyalo, M.
Uganda, Entebbe
Uganda Virus Research Institute
Zalwango, Aisha
Uganda, Entebbe
Uganda Virus Research Institute
Generous, Lillian
Uganda, Entebbe
Uganda Virus Research Institute
Khauka, P.
Uganda, Entebbe
Uganda Virus Research Institute
Rutikarayo, N.
Uganda, Entebbe
Uganda Virus Research Institute
Nakahima, William
Uganda, Entebbe
Uganda Virus Research Institute
Mugisha, Annet
Uganda, Entebbe
Uganda Virus Research Institute
Omwony, W.
Uganda, Entebbe
Uganda Virus Research Institute
Nakiyingi, Jessica S.
Uganda, Entebbe
Uganda Virus Research Institute
Muyingo, Sylvia Kiwuwa
Uganda, Entebbe
Uganda Virus Research Institute
Hughes, Peter
Uganda, Entebbe
Uganda Virus Research Institute
Katabira, Elly Tebasoboke
Uganda, Kampala
Mulago Hospital
Oyugi, Jessica H.
Uganda, Kampala
Mulago Hospital
Ronald, Allan R.
Uganda, Kampala
Mulago Hospital
Kambungu, A.
Uganda, Kampala
Mulago Hospital
Martin, John C.
Uganda, Kampala
Mulago Hospital
Nalumenya, Ruth
Uganda, Kampala
Mulago Hospital
Nairubi, R.
Uganda, Kampala
Mulago Hospital
Statistics
Citations: 98
Authors: 98
Affiliations: 4
Identifiers
Doi:
10.1097/QAD.0b013e3282f2d760
Research Areas
Environmental
Sexual And Reproductive Health
Study Design
Randomised Control Trial
Cohort Study
Study Locations
Uganda
Zimbabwe