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

References

Centers for Disease Control and Prevention MMWR Morbidity Mortality Weekly Report. Scale-up of HIV Viral Load Monitoring — Seven Sub-Saharan African Countries. Centers for Disease Control and Prevention MMWR Morbidity Mortality Weekly. 2015;64(46):

Holmes CB, Sanne I. Changing models of care to improve progression through the HIV treatment cascade in different populations. Curr Opin HIV AIDS. 2015;10:447–50.

Khabala KB, Edwards JK, Baruani B, Sirengo M, Musembi P, Kosgei RJ, et al. Medication Adherence Clubs: a potential solution to managing large numbers of stable patients with multiple chronic diseases in informal settlements. Trop Med Int Health. 2015;20(10):1265-70.

Brennan AT, Long L, Maskew M, Sanne I, Jaffray I, MacPhail P, et al. Outcomes of stable HIV-positive patients down-referred from a doctor-managed antiretroviral therapy clinic to a nurse-managed primary health clinic for monitoring and treatment. AIDS. 2011;25:2027–36.

Dawson L, Klingman K, Marrazzo J. Addressing standards of care in resource-limited settings J Acquir Immune Defic Syndr. 2014;65(1):10-4.

Pratt B, Zion D, Lwin KM, Cheah PY, Nosten F, Loff B. Ancillary Care: From Theory to Practice in Int Clin Res Public Health Ethics. 2013;6(2):154–69.

Sofaer N. Reciprocity-Based Reasons For Benefiting Research Participants: Most Fail, The Most Plausible Is Problematic. Bioethics. 2014;28(9):456-71.

Millum J. Post-trial Access to Antiretrovirals: Who Owes What to Whom? Bioethics. 201125(3):145–54.

Dawson L, Zwerski S. Clinical Trial Design For Hiv Prevention Research: Determining Standards Of Prevention. 2015;29(5):316-23.

Iserson KV, Biros MH, James HC. Challenges in International Medicine: Ethical Dilemmas, Unanticipated Consequences, and Accepting Limitations. Acad Emergency Med. 2012;19(6):683-92.

Pratt B, Loff B. A framework to link international clinical research to the promotion of justice in global health. Bioethics. 2014;28(8):387-96.

Godfrey C, Payton M, Tasker S, Proestel S, Schouten JT. Ensuring Participant Safety and Trial Integrity with Clinical Trials Oversight. J Acquir Immune Defic Syndr. 2014;65(1):40–3.

Lockman S, Hughes MD, McIntyre J, Zheng Y, Chipato T, Conradie F, et al. Antiretroviral therapies in women after single-dose nevirapine exposure. N Engl J Med. 2010;363(16):1499-509.

Lockman S, Hughes M, Sawe F, Zheng Y, McIntyre J, Chipato T, et al. Nevirapine- versus lopinavir/ritonavir-based initial therapy for HIV-1 infection among women in Africa: a randomized trial. PLoS Med. 2012;9(6):e1001236.

The Belmont Report. 1979. Available at http://www.hhs.gov/ohrp/ humansubjects/guidance /belmont.html. Accessed on 23 November 2016.

Maman D, Zeh C, Mukui I, Masson BKS, Opolo V, Szumilin E, et al. Cascade of HIV care and population viral suppression in a high-burden region of Kenya. AIDS. 2015;29:1557–65.

Fox MP, Rosen S. Patient retention in antiretroviral therapy. programs up to three years on treatment in sub-Saharan Africa, 2007–2009: systematic review. Trop Med Intl Health. 2010;15(1):1–15.

National AIDS and STI Control Programme (NASCOP), Kenya. Kenya AIDS Indicator Survey 2012: Final Report. Nairobi, NASCOP. 2014.

Downloads

Published

2017-01-25

Issue

Section

Original Research Articles