Excellent retention, virologic and clinical outcomes after transitioning from an antiretroviral treatment clinical trial to locally-provided care and treatment in Africa

Authors

  • Fredrick Sawe Kenya Medical Research Institute/Walter Reed Project Kericho, Kenya; U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, United States of America (USA); Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA
  • Michael D. Hughes Harvard School of Public Health, Boston, MA, USA
  • Yajing Bao Harvard School of Public Health, Boston, MA, USA
  • Evelyn Hogg Social & Scientific Systems, Inc., Silver Spring, MD USA
  • Douglas Shaffer Kenya Medical Research Institute/Walter Reed Project Kericho, Kenya; U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, United States of America (USA)
  • Jacob Phulusa University of North Carolina Project, Kamuzu Central Hospital, Lilongwe, Malawi
  • Tebogo Kakhu Botswana Harvard School of Public Health AIDS Initiative Partnership, Gaborone, Botswana
  • Francesca Conradie University of Witwatersrand Clinical HIV Research Unit Johannesburg South Africa
  • Margaret Kasaro Centre for Infectious Disease Research in Zambia , Lusaka , Zambia
  • Rosie Mngqbisa University of KwaZulu-Natal, Durban, South Africa
  • Abraham Siika Department of Internal Medicine, College of Health Sciences, School of Medicine, Moi University, Eldoret, Kenya
  • Diana Atwiine Joint Clinical Research Centre Kampala, Uganda
  • Tsungai Chipato University of Zimbabwe, Harare, Zimbabwe
  • James McIntyre Anova Health Institute, Johannesburg, South Africa
  • Judith Currier University of California Los Angeles, Los Angeles, CA, USA
  • Shahin Lockman Botswana Harvard School of Public Health AIDS Initiative Partnership, Gaborone; BotswanaBrigham and Women’s Hospital, Boston, Massachusetts, USA

DOI:

https://doi.org/10.18203/2349-3259.ijct20170307

Keywords:

HIV, Antiretroviral therapy, Post clinical trial care, Resource limited settings

Abstract

Background: Little is known about outcomes among clinical trial participants following completion of study-provided care and treatment in resource limited settings. We sought to describe outcomes among HIV clinical trial participants after transitioning to local routine care in Africa.

Methods: In the OCTANE study, 741 women with CD4 <200 cells/mm3 in 7 African countries were randomized to initiate antiretroviral treatment (ART) with tenofovir/emtricitabine (TDF/FTC) plus either lopinavir/ritonavir (LPV/r) or nevirapine (NVP). When study-specified ART ended (48-191 weeks after study entry), participants transitioned to locally-provided HIV care and non-study ART. Consenting participants were interviewed and had toxicity labs, CD4 and HIV-1 RNA testing, and clinical outcomes assessed at 12 and 72 weeks after transition to local care.

Results: Five hundred thirteen (77%) of the 669 women in follow-up at completion of the interventional trial participate in the extended follow-up. 513 women, 476 (93%) had HIV-1 RNA <400 cp/mL at time of transition, and 489 (95%) completed follow-up.  Seventy-seven women (19%) had a total of 99 antiretroviral regimen changes during post-trial follow-up. 30% of the 99 regimen changes-were due to lack of local drug availability. Thirteen (3%) women had Grade ≥3 laboratory abnormalities and 3 experienced worsening of the WHO HIV stage. Two women died. Eighty-nine percent of 484 with results had HIV-1 RNA ≤400 cp/mL at 72 weeks after transition to local non-study HIV care and treatment.  

Conclusions: The vast majority of women were able to continue key components of their ART and to maintain virologic suppression through 72 weeks of locally-provided post-study care.

Trial registration: ClinicalTrials.gov NCT00089505

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Author Biography

Fredrick Sawe, Kenya Medical Research Institute/Walter Reed Project Kericho, Kenya; U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, United States of America (USA); Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA

Senior Deputy Director

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Published

2017-01-25

How to Cite

Sawe, F., Hughes, M. D., Bao, Y., Hogg, E., Shaffer, D., Phulusa, J., Kakhu, T., Conradie, F., Kasaro, M., Mngqbisa, R., Siika, A., Atwiine, D., Chipato, T., McIntyre, J., Currier, J., & Lockman, S. (2017). Excellent retention, virologic and clinical outcomes after transitioning from an antiretroviral treatment clinical trial to locally-provided care and treatment in Africa. International Journal of Clinical Trials, 4(1), 39–44. https://doi.org/10.18203/2349-3259.ijct20170307

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Original Research Articles