Publications

Funding for clinical research |drugs, vaccines, microbicides, diagnostics | HIV/AIDS, tuberculosis, malaria, other infectious diseases |sub-Saharan Africa

Dr Agnes Kiragga

Uganda

EDCTP portfolio: Career Development Fellowships

Dr Agnes Kiragga helps mothers and infants to return to HIV care and thus seeks to diminish high drop-out rates which hinder elimination of mother-to-child HIV transmission.

Tracing HIV-positive pregnant women and their babies

Sub-Saharan Africa carries the heaviest burden of HIV and more than 70% of persons presenting to care are women. Women who initiate ART and disengage from care are at risk of transmitting the HIV virus to their infant pre and post-delivery. The alarmingly high dropout rates observed among HIV-positive pregnant women may alter the general success of option B+* and hinder the successful elimination of mother-to-child transmission. The challenge is to trace HIV-positive pregnant women and bring them back to treatment.

The challenge

The study aims to trace HIV- positive pregnant women who were previously started on antiretroviral therapy through the Option B+ strategy and later dropped out of care. The aim is to trace these disengaged women and link them back to care while ascertaining the HIV status of babies born to these women as compared to those born to women who were retained in care. Furthermore, the study aims to use the estimates of vertical transmission in the retained and non-retained women to produce estimates of vertical transmission with option B+, while adjusting for loss to follow-up among these women.

The project

The study will contribute to maternal and child health by reducing mother-to-child transmission by bringing mothers back to care. The data generated may be critical to the roll-out of Option B+ in sub-Saharan Africa. Dropout rates among HIV-positive pregnant women may alter the success of option B+ and hinder successful elimination of mother-to-child transmission.

* Option B+: prevention of vertical transmission for pregnant women living with HIV in which treatment for life is immediately offered regardless of CD4 count)

Impact


test the safety and efficacy of this new formulation in young children

Bringing antiretroviral drugs to children

The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

EDCTP portfolio: HIV & HIV-associated infections

The challenge

Sub-Saharan Africa carries the heaviest burden of HIV and more than 70% of persons presenting to care are women. Women who initiate ART and disengage from care are at risk of transmitting the HIV virus to their infant pre and post-delivery. The alarmingly high dropout rates observed among HIV-positive pregnant women may alter the general success of option B+* and hinder the successful elimination of mother-to-child transmission. The challenge is to trace HIV-positive pregnant women and bring them back to treatment.

The study aims to trace HIV- positive pregnant women who were previously started on antiretroviral therapy through the Option B+ strategy and later dropped out of care. The aim is to trace these disengaged women and link them back to care while ascertaining the HIV status of babies born to these women as compared to those born to women who were retained in care. Furthermore, the study aims to use the estimates of vertical transmission in the retained and non-retained women to produce estimates of vertical transmission with option B+, while adjusting for loss to follow-up among these women.

The project

The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.

The study will contribute to maternal and child health by reducing mother-to-child transmission by bringing mothers back to care. The data generated may be critical to the roll-out of Option B+ in sub-Saharan Africa. Dropout rates among HIV-positive pregnant women may alter the success of option B+ and hinder successful elimination of mother-to-child transmission.

* Option B+: prevention of vertical transmission for pregnant women living with HIV in which treatment for life is immediately offered regardless of CD4 count)

ratios forfixed-dose combinations and on appropriatedosage according to weight. 

The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.

Impact

L’homme RF et al. Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets. AIDS. 2008;22(5):557–65.

Mulenga V et al. Abacavir, zidovudine, or stavudine as paediatric tablets for African HIVinfected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial. Lancet Infect Dis. 2016;16(2):169–79.

WHO. Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2010.

WHO. Consolidated guidelines on the use of antiretroviral drugs
for treating and preventing

HIV infection: Recommendations for a public health approach
(second edition). 2016

Projects: Children with HIV in Africa Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS): CHAPAS-1 and -3

Project lead: Professor Chifumbe Chintu, University Teaching Hospital, Zambia (CHAPAS-1); Dr Veronica Mulenga, University Teaching Hospital, Zambia (CHAPAS-3)

Target population(s): Children with HIV

Sample size: 71 (CHAPAS-1); 480 (CHAPAS-3)

Countries involved: Ireland, the Netherlands, the UK, the USA, Zambia (CHAPAS-1); Uganda, Zambia (CHAPAS-3)

Project duration: 2005–2009 (CHAPAS-1); 2010 –2011 (CHAPAS-3)

EDCTP funding: €1.2M (CHAPAS-1); €4.6M (CHAPAS-3)

Total project funding: €1.2M (CHAPAS-1); €5.0M