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

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

Issue

Vol. 4 No. 1 (2017): January-March 2017

Section

Original Research Articles