Lamivudine/Nevirapine/Stavudine

Before the launch of the EDCTP a decade ago, few African groups outside of the northern countries and South Africa were capable of conducting clin. trials that met international standards, according to Abdoulaye Djimde,́ an EDCTP-funded malaria researcher at the University of Bamako in Mali."The advent of EDCTP was really a game changer, in terms of not only investing in training Africans so that they can run the trials themselves but also in demonstrating that it can be done."A few projects funded in part by the EDCTP have already posted some promising results.For example, one study conducted at five sites in Burkina Faso, Kenya and South Africa showed that three antiretroviral drugs given in combination throughout pregnancy and breastfeeding are more effective at preventing the transmission of HIV from pregnant women or breastfeeding mothers to their children than the conventional regimen consisting of two antiretroviral agents given during pregnancy and one week after delivery (Lancet Infect. Dis.11, 171-180, 201110.1016/S1473-3099(10)70288-7).Those results contributed to the revision in 2010 of the World Health Organization′s guidelines for the prevention of mother-to-child transmission of the virus to recommend triple-antiretroviral therapy during pregnancy and breastfeeding.Other EDCTP-backed studies led to the approval by the US Food and Drug Administration of two anti-HIV drug combinations formulated especially for children-Triomune Baby and Triomune Junior, manufactured by the India-based pharmaceutical company Cipla.Despite the program′s relatively limited scientific achievements thus far, Gray says it has made great strides in training scientists and establishing collaborations.For example, the EDCTP has launched four African Regional Networks of Excellence promoting partnerships between researchers in the continent (see Nat. Med.16, 9, 201010.1038/nm0110-9a).It has also been credited with helping to establish ethics committees and regulatory frameworks in many African countries and providing funds to the South African Cochrane Center to establish the Pan African Clin. Trials Registry, a repository of information about the studies conducted on the continent.The new phase of the program seeks to leverage the capacity developed during the past decade to expand its focus to include neglected infectious diseases such as schistosomiasis, African sleeping sickness, diarrheal diseases and respiratory infections."Now that we have this structure, why not add a little bit more, because it′s more cost effective," says EDCTP executive director Charles Mgone."It′s like we already have the mother ship, and the other satellites can come and dock on it."Also, for the first time, the EDCTP is granting full membership to African countries-putting them on an equal footing with European members when it comes to governance, policy decision-making and participation in the program-in exchange for an annual contribution of at least [euro]200,000.Membership gives African countries a financial stake in EDCTP-funded projects and will help to ensure that the research agenda is aligned with the health needs of the continent.As of early May, nine sub-Saharan African countries had joined the partnership.As the program unfolds in the coming months and years, Mgone says that the EDCTP is looking for new ways to collaborate with other funding organizations and pharmaceutical companies.Industry has traditionally participated in EDCTP-funded projects by developing and donating drugs and vaccines to clin. studies, but Mgone hopes to form collaborations that will build even more capacity and fund bigger trials than before.As an example of what′s possible, Mgone points to the Pan African Consortium for the Evaluation of Antituberculosis Antibiotics (PanACEA), an alliance between three European universities, 12 African clin. trial sites and the pharmaceutical companies Bayer, Sequella and Sanofi-Aventis that was established by the EDCTP in 2008 to simplify and shorten the duration of tuberculosis treatment.In addition, the EDCTP developed a fellowship scheme in 2013 that enables African researchers to work for 6-18 mo at European pharmaceutical companies to gain advanced skills and expertise related to clin. trials."We′re really looking to make [EDCTP2] more of a joint partnership between the developing and developed countries," Mgone says."The initial phase was to kick-start the engine," he says, "but if things are moving, you need to crank up the machinery."

Thin layer chromatography (TLC) can be used to perform therapeutic drug monitoring in resource-limited settings, where more expensive analytical methods, such as high-performance liquid chromatography or liquid chromatography-mass spectrometry, are not feasible.

The aim of this cross-sectional study was to compare saliva concentrations of nevirapine (NVP) with self-reported adherence in patients on NVP-containing antiretroviral treatment at Kilimanjaro Christian Medical Centre, Moshi, Tanzania.

HIV-infected patients using a combination of zidovudine + lamivudine + NVP, or stavudine + lamivudine + NVP, for more than 4 weeks were included. Saliva samples were collected using dental cotton rolls impregnated with citric acid (20 mg). Saliva NVP concentrations were analyzed using TLC. Adherence to ARV medication was assessed by self-reporting using the Morisky scale.

Of the 91 study participants, 79 (86.8%) had therapeutic saliva NVP concentrations (ie, >1.75 mg/L) and 12 (13.2%) had subtherapeutic concentrations. Self-reported adherence among the study participants was high in 62 participants (68.1%), moderate in 24 (26.4%), and low in 5 (5.5%). Fifty-seven (91.9%) of the study participants with high self-reported adherence had therapeutic saliva NVP concentrations. Of the 5 participants with low self-reported adherence, 3 had therapeutic NVP concentrations.

A high proportion of patients had therapeutic NVP saliva concentrations as measured by TLC, which showed a good agreement with self-reported adherence.