full name | Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex With Men |
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other names | CT02720094 |
sponsor | ViiV Healthcare, Gilead Sciences [1] |
number of participants | 4500 [1] |
start | 20 December 2016 [2] |
primary completion | June 2020 [1] |
HPTN 083 is a 2016 clinical trial which compares cabotegravir injections with oral use of Emtricitabine/tenofovir as pre-exposure prophylaxis ("PrEP") for prevention of HIV/AIDS.
The study seeks to test injectable PrEP as a way to remedy adherence for many patients on a daily pill regimen. [3]
HPTN 083 is the first large scale phase III clinical trial of cabotegravir. [4]
In February 2016 researchers presented the results of the ECLAIR study. [5] That study examined cabotegravir and found no serious safety concerns. [5]
The research is a collaboration of Gilead Sciences, HIV Prevention Trials Network, ViiV Healthcare, National Institute of Allergy and Infectious Diseases. [6]
Local study sites will include John H. Stroger Jr. Hospital of Cook County. [7]
On May 18, 2020, HPTN announced that the long-acting injections had been found to be a highly effective treatment. [8]
Microbicides for sexually transmitted diseases are pharmacologic agents and chemical substances that are capable of killing or destroying certain microorganisms that commonly cause human infection.
Emtricitabine, with trade name Emtriva, is a nucleoside reverse-transcriptase inhibitor (NRTI) for the prevention and treatment of HIV infection in adults and children.
Post-exposure prophylaxis, also known as post-exposure prevention (PEP), is any preventive medical treatment started after exposure to a pathogen in order to prevent the infection from occurring.
Tenofovir disoproxil, sold under the trade name Viread among others, is a medication used to treat chronic hepatitis B and to prevent and treat HIV/AIDS. It is generally recommended for use with other antiretrovirals. It may be used for prevention of HIV/AIDS among those at high risk before exposure, and after a needlestick injury or other potential exposure. It is sold both by itself and together in combinations such as emtricitabine/tenofovir, efavirenz/emtricitabine/tenofovir, and elvitegravir/cobicistat/emtricitabine/tenofovir. It does not cure HIV/AIDS or hepatitis B. It is available by mouth as a tablet or powder.
Efavirenz (EFV), sold under the brand names Sustiva among others, is an antiretroviral medication used to treat and prevent HIV/AIDS. It is generally recommended for use with other antiretrovirals. It may be used for prevention after a needlestick injury or other potential exposure. It is sold both by itself and in combination as efavirenz/emtricitabine/tenofovir. It is taken by mouth.
Emtricitabine/tenofovir, sold under the brand name Truvada among others, is a fixed-dose combination antiretroviral medication used to treat and prevent HIV/AIDS. It contains the antiretroviral medications emtricitabine and tenofovir disoproxil. For treatment, it must be used in combination with other antiretroviral medications. For prevention before exposure, in those who are at high risk, it is recommended along with safer sex practices. It does not cure HIV/AIDS. Emtricitabine/tenofovir is taken by mouth.
Pre-exposure prophylaxis (PrEP) is the use of medications used to prevent the spread of disease in people who have not yet been exposed to a disease-causing agent, usually a virus. The term typically refers to the specific use of antiviral drugs as a strategy for HIV/AIDS prevention. PrEP is one of a number of HIV prevention strategies for people who are HIV negative but who also have a higher risk of acquiring HIV, including sexually active adults at increased risk of HIV, people who engage in injection drug use, and serodiscordant sexually active couples.
The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. HPTN studies evaluate new HIV prevention interventions and strategies in populations and geographical regions that bear a disproportionate burden of infection. The HPTN is committed to the highest ethical standards for its clinical trials and recognizes the importance of community engagement in all phases of the research process.
Integrase inhibitors (INIs) are a class of antiretroviral drug designed to block the action of integrase, a viral enzyme that inserts the viral genome into the DNA of the host cell. Since integration is a vital step in retroviral replication, blocking it can halt further spread of the virus. Integrase inhibitors were initially developed for the treatment of HIV infection, but have been applied to other retroviruses. The class of integrase inhibitors called integrase strand transfer inhibitors (INSTIs) are in established medical use. Other classes, such as integrase binding inhibitors (INBIs), are still experimental.
Rilpivirine, sold under the brand names Edurant and Rekambys, is a medication, developed by Tibotec, used for the treatment of HIV/AIDS. It is a second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) with higher potency, longer half-life and reduced side-effect profile compared with older NNRTIs such as efavirenz.
iPrEx was a phase III clinical trial to determine whether the antiretroviral medication emtricitabine/tenofovir could safely and effectively prevent HIV acquisition through sex in men who have sex with men and transgender women. iPrEx was the first human study of an HIV prevention strategy known as pre-exposure prophylaxis, or PrEP.
CONRAD is a non-profit organization scientific research organization that works to improve the reproductive health of women, especially in developing countries. CONRAD was established in 1986 under a cooperative agreement between Eastern Virginia Medical School (EVMS) and the United States Agency for International Development(USAID). CONRAD’s products are developed primarily for women in low-resource settings, in that they are designed to be safe, affordable and user-friendly. CONRAD is led by Scientific and Executive Director Gustavo Doncel, M.D., Ph.D. Primary funding for CONRAD comes from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Agency for International Development (USAID), with additional funding from The Bill & Melinda Gates Foundation and the National Institutes of Health (NIH).
HIV prevention refers to practices that aim to prevent the spread of the human immunodeficiency virus (HIV). HIV prevention practices may be undertaken by individuals to protect their own health and the health of those in their community, or may be instituted by governments and community-based organizations as public health policies.
Tenofovir alafenamide, sold under the brand name Vemlidy, is a hepatitis B virus (HBV) nucleotide reverse transcriptase inhibitor medication for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease. It is taken by mouth.
A rectal microbicide is a microbicide for rectal use. Most commonly such a product would be a topical gel inserted into the anus so that it make act as protection against the contract of a sexually transmitted infection during anal sex.
Cabotegravir, sold under the brand name Vocabria among others, is a antiretroviral medication used for the treatment of HIV/AIDS. It is available in the form of tablets and as an intramuscular injection, as well as in an injectable combination with rilpivirine under the brand name Cabenuva.
National AIDS Trust v NHS Commissioning Board, [2016] EWHC 2005 (Admin), was a court case before the High Court of Justice seeking judicial review regarding National Health Service funding for pre-exposure prophylaxis.
Bictegravir is a second-generation integrase inhibitor (INSTI) class that was structurally derived from an earlier compound dolutegravir by scientists at Gilead Sciences; in vitro and clinical results were presented by Gilead in the summer of 2016. In 2016, bictegravir was in a Phase 3 trial as part of a single tablet regimen in combination with tenofovir alafenamide (TAF) and emtricitabine (FTC) for the treatment of HIV-1 infection and the combination drug bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) was approved for use in the United States in 2018.
Margaret Denise Portman was a British medical doctor who specialised in sexual health. She was an advocate for pre-exposure prophylaxis medication (PrEP) to prevent new HIV cases.
In January 2018, the provincial government of British Columbia (BC) began providing individuals at high risk of HIV infection with pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) at no cost. High risk individuals include men and trans women who have sex with men, people who inject drugs, and people who have sex with people living with HIV. One year following this policy change, which is delivered as part of the British Columbia Centre for Excellence in HIV/AIDS (BC-CfE)'s Drug Treatment Program, almost 3,300 people have been prescribed with PrEP or PEP.
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