HIV and Multipurpose Prevention Technology
In 1988, CONRAD pioneered the microbicide research field by developing the first spermicide/virucide screening program, which incorporated assays to evaluate compounds for efficacy, cervicovaginal safety, pharmacokinetics and pharmacodynamics. This preclinical testing algorithm is now a reference for the field. Since then, CONRAD’s network of scientists has evaluated thousands of compounds, and has been instrumental in advancing several microbicides into late phase trials, including tenofovir gel. Vaginally administered tenofovir gel was the first microbicide to prove that a topical product could be effective in reducing HIV and HSV-2 infections in certain populations.
CONRAD continues to develop novel compounds and new delivery methods for microbicides, including the development of multipurpose prevention technology (MPT) products that deliver varied combinations of HIV prevention, other STI prevention, and contraception. MPTs can provide women with a simplified, more acceptable, and potentially less expensive choice for protection.
In 2017, there were 1.8 million new human immunodeficiency virus (HIV) infections worldwide, with a total of 36.9 million people living with HIV (UNAIDS 2017). Adolescent girls and young women aged 15–24 years are at particularly high risk of HIV infection, accounting for 20% of new HIV infections among adults globally in 2015, despite accounting for just 11% of the adult population (Global AIDS Update, UNAIDS 2016). Tremendous progress against AIDS over the last 15 years has inspired a global commitment to end the epidemic by 2030. In order to reduce HIV, one of the highest priorities is to develop stable, safe, effective, and acceptable products that can successfully reduce HIV sexual transmission (Prevention Gap Report, UNAIDS 2016).
CONRAD is committed to doing our part to ensure that every woman has the ability to protect herself from disease, and to decide the timing of pregnancy and size of her family.
STUDIES
A10-113 – Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Tenofovir 1% Gel Using the BAT 24 Regimen Versus Daily and Pericoital Dosing
(Clinicaltrials.gov Identifier: NCT01369303)
A10-114 – Assessing the Effect of Contraception and the Menstrual Cycle on Pharmacokinetics, Pharmacodynamics, and Vaginal Safety in Tenofovir Vaginal Gel Users
(Clinicaltrials.gov Identifier: NCT01421368)
A11-117 – A Phase I Clinical Trial Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Disintegration Time of Vaginal Tablets Containing Tenofovir and/or Emtricitabine
(Clinicaltrials.gov Identifier: NCT01694407)
A11-118 – In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products
(Clinicaltrials.gov Identifier: NCT01813162)
A12-124 – Influence of Female Reproductive Cycle and Menopause on Cervicovaginal Tissue Susceptibility to HIV-1 Infection and Tenofovir 1% Gel Activity
(Clinicaltrials.gov Identifier: NCT01810315)
FACTS 001 – A Phase III, Multi-Centre, Randomised Controlled Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel in the Prevention of Human Immunodeficiency Virus Type 1 Infection in Women, and to Examine Effects of the Microbicide on the Incidence of Herpes Simplex Virus Type 2 Infection
(Clinicaltrials.gov Identifier: NCT01386294)
A13-128 – Phase I One-Month Safety, Pharmacokinetic, Pharmacodynamic, and Acceptability Study of Intravaginal Rings Releasing Tenofovir and Levonorgestrel or Tenofovir Alone
(Clinicaltrials.gov Identifier: NCT02235662)
D15-134 – Assessing the Disintegration, Safety, and Acceptability of Placebo Vaginal Inserts for the Delivery of Vaginal Products
(Clinicaltrials.gov Identifier: NCT02534779)
A15-137 Exploratory Pharmacokinetic and Pharmacodynamic Study of Oral F/TAF for the Prevention of HIV Acquisition
(Clinicaltrials.gov Identifier: NCT02904369)
A15-138 - PHASE I, 90-DAY SAFETY, PHARMACOKINETIC, AND PHARMACODYNAMIC STUDY OF INTRAVAGINAL RINGS RELEASING TENOFOVIR AND LEVONORGESTREL
(Clinicaltrials.gov Identifier: NCT03279120)
A15-140 Phase I Exploratory Pharmacodynamic Study of Tenofovir-Based Products
(Clinicaltrials.gov Identifier: NCT02722343)
CAPRISA 004 – Phase IIb trial to assess the safety and effectiveness of the vaginal microbicide 1% tenofovir gel for the prevention of HIV infection in women in South Africa
(Clinicaltrials.gov Identifier: NCT00441298)