SELECTED CLINICAL TRIAL EXPERIENCE
A summary of DF/Net Research trials are presented below. For more detail on selected client trials, please refer to the links provided on the left.
Facet Biotech
Phase I
dose escalation treatment study in subjects with advanced multiple myeloma.
Phase 1b trial
to evaluate the safety and PK of combination drug therapy in the treatment of subjects with Stage IIIB/IV Non-small cell lung cancer.
St. Stephens Aids Trust
Phase I/II, PrEP trial
to evaluate safety, tolerability, and PK of an NNRTI in HIV negative volunteers.
Oncogenex Pharmaceuticals
Phase I study evaluating the safety and tolerability of heat shock protein therapy in subjects with breast, prostate, ovary, NSCL or bladder cancers.
ICRC (International Clinical Research Center)
Partners HSV/HIV Transmission Study: Phase III, multi-site, randomized, double-blind, placebo-controlled study to determine whether the use of acyclovir by people who are infected with both HSV-2 and HIV can reduce the likelihood that they will transmit HIV to their HIV uninfected sexual partners.
Partners PrEP Study: Phase III, multi-site, randomized, double-blind, placebo-controlled study of tenofovir and emtricitabine/tenofovir for pre-exposure prophylaxis (PrEP) to reduce HIV acquisition among HIV uninfected partners in HIV discordant couples.
Couples Observational Study:
Couples Observational Study: Multi-site, prospective, observational cohort of heterosexual HIV discordant couples.
IPM (International Partnership for Microbicides)
Three phase I/II studies
to evaluate the safety and acceptability of a vaginal microbicide gel.
One safety and pharmacokinetic trial
to assess delivery of a microbicide gel from a vaginal ring.
One observational study
to estimate HIV incidence among sexually active, adult females.
One study
on the efficacy and safety of a contraceptive vaginal ring.
Gladstone Institute/University of California - San Francisco, CA, USA / Associacion Civil Impacta Salud y Educacion, Lima, Peru
Chemoprophylaxis for HIV Prevention in Men This is a randomized, blinded, placebo-controlled clinical trial to determine if daily oral co-formulated emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (FTC/TDF) decreases HIV-1 acquisition and has acceptable safety in initially HIV-1-uninfected men who are receiving standard prevention interventions.
Key Study Facts:
2499 participants identifying as men who have sex with men (MSM)
11 study sites in the Brazil, Ecuador, Peru, South Africa, Thailand, and the United States
Infectious Disease Research Institute (IDRI) – Seattle, WA USA
Phase I and II Leishmaniasis Vaccine Studies IDRI, working with Corixa Corporation (now GSK), developed the world’s first defined vaccine candidate for leishmaniasis, which has been tested in the USA, Peru, Brazil, Columbia, India and Venezuela, and is currently being tested in Peru and Sudan.
Leishmaniasis is a widespread parasitic disease with frequent epidemics in the Indian subcontinent., Africa, and Latin America. The World Health Organization has declared developing a vaccine for the disease to be a priority.
The protozoan parasites that are responsible for Leishmania are transmited by the bite of a sand fly. The visceral form of the disease causes fatal infections of internal organs, while the cutaneous form causes serious skin lesions. It is estimated that about 500,000 new cases of the visceral form occur each year. Most of these deaths occur in children. The cutaneous forms often leaves its victims permanently disfigured.
Leishmaniasis is now out of control in many areas, and the number of cases is increasing-even in some developed countries of southern Europe-as a result of HIV infection. Available drugs are toxic, expensive, and require long-term daily injections. The emergence of drug resistant visceral leishmaniasis has increased the urgency of developing improved therapeutic strategies.