HPTN 083
full nameSafety 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
other namesCT02720094
sponsorViiV Healthcare, Gilead Sciences[1]
number of participants4500[1]
start20 December 2016[2]
primary completionJune 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]

References

  1. 1 2 3 "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". clinicaltrials.gov. 3 February 2017. Retrieved 6 February 2017.
  2. ↑ "NIH Launches First Large Trial of a Long-Acting Injectable Drug for HIV Prevention | NIH: National Institute of Allergy and Infectious Diseases". www.niaid.nih.gov. 20 December 2016. Retrieved 6 February 2017.
  3. ↑ Surugue, Léa (28 December 2016). "New PrEP drug could be a 'game-changer' to protect people from HIV infection". International Business Times UK. Retrieved 6 February 2017.
  4. ↑ Rosa, Kristi (22 December 2016). "Will Cabotegravir be a Game-changer in HIV Prevention?". ContagionLive. Retrieved 6 February 2017.
  5. 1 2 Cairns, Gus (11 November 2016). "The 'long tail' problem: injected-PrEP trial will be extended due to persistence of drug in companion study". Aidsmap. Retrieved 6 February 2017.
  6. ↑ "Viiv HealthCare initiates Phase III HPTN 083 study of cabotegravir versus Truvadafor Pre-Exposure Prophylaxis (PrEP)to prevent HIV infection., 22-Dec-16". Medthority.com. 22 December 2016. Retrieved 6 February 2017.
  7. ↑ Thomas, Monifa (9 January 2017). "CCHHS Part of First Study to Test Efficacy and Safety Of A New HIV-Prevention Medication". Daily Southtown. Retrieved 6 February 2017.
  8. ↑ "Long-acting injectable cabotegravir is highly effective for the prevention of HIV infection in cisgender men and transgender women who have sex with men | The HIV Prevention Trials Network". www.hptn.org. Retrieved 2020-05-18.
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