The National Institutes of Health has launched two large HIV clinical trials in Africa: one to investigate the efficacy of a long-acting injectable anti-HIV drug and one to test an experimental new HIV vaccine.
The first is a phase 3 trial comparing an injectable version of the investigational integrase inhibitor cabotegravir with pre-exposure prophylaxis (PrEP) using daily oral Truvada (emtricitabine). Researchers aim to recruit 3,200 sexually active women from across Southern and Eastern Africa, and follow them for an average of 2.6 years.
The long-acting injectable aims to address an ongoing issue of adherence with the once-daily oral Truvada, said Anthony S. Fauci , MD, director of the National Institute of Allergy and Infectious Diseases, in a written statement.
“Taking a daily pill can be challenging for some people. For some women, a long-acting injectable form of protection may be an easier, more desirable and discreet alternative,” he said.
Women currently account for 58% of new HIV infections in adults in Southern and Eastern Africa, but preventive tools can be difficult to negotiate with a new partner.
A similar study is already underway in men and transgender women who have sex with men. The study is cofunded by ViiV Healthcare and the Bill & Melinda Gates Foundation, and ViiV Healthcare and Gilead Sciences are providing the study medications.
Meanwhile, the NIH has also partnered with Janssen Vaccines & Prevention B.V. to conduct the phase 2b proof-of-concept “Imbokodo” study of a quadrivalent HIV vaccine regimen using “mosaic” immunogens, which means the vaccine components are designed to trigger an immune response against a variety of HIV strains.
Preclinical studies in monkeys suggest this approach can protect against HIV infection, and two early-stage clinical trials in humans showed the vaccine was well tolerated and generated immune responses against HIV in healthy individuals.
The four doses of the vaccine will be spread out over a year, and the final two doses will be given together with doses of an HIV protein, clade C gp140, and an aluminum phosphate adjuvant to boost immune responses. The study has already begun to immunize some of the 2,600 HIV-negative sub-Saharan African women to be recruited for the study.
The study is sponsored by Janssen Vaccines & Prevention B.V. and cofunded by the Bill & Melinda Gates Foundation and the NIH.
SOURCE: National Institute of Allergy and Infectious Diseases News Releases Nov. 30, 2017.
