HPTN Launches HPTN 083-01

Jul 29, 2020

Adolescent boysThe HIV Prevention Trials Network (HPTN) has launched its first study exclusively enrolling adolescents under the age of 18. HPTN 083-01 is evaluating whether a pre-exposure prophylaxis (PrEP) regimen containing long-acting injectable cabotegravir (CAB LA) is safe and acceptable for adolescents assigned male at birth. Twenty-one percent (21%) of new HIV acquisitions in the United States occur among young people. Most of these infections occur due to sexual activity and about half of the youth who are living with HIV don’t know it. 

Results from the HPTN 083 study released at AIDS 2020 demonstrated cabotegravir was better than daily oral tenofovir/emtricitabine (TDF/FTC) for PrEP. The results from HPTN 083 make studying the safety and acceptability of CAB LA in adolescents even more important.  

HPTN 083-01 will enroll about 50 adolescents, assigned male at birth, under the age of 18 at study sites in Boston, Chicago, and Memphis, TN.

Participants will move through the study in 3 steps: 

  • Step 1: Participants will take one CAB pill every day for five weeks 
  • Step 2: Participants will receive a total of 5 CAB injections over 6 months 
  • Step 3: Participants will come to the clinic for study visits quarterly and receive Truvada for  PrEP for about one year. 
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This is the first collaboration between the HPTN and the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN), part of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). HPTN 083-01 is sponsored by the Division of AIDS (DAIDS), United States (U.S.) National Institute of Allergy and Infectious Diseases (NIAID), and NICHD, all parts of the U.S. National Institutes of Health (NIH). Additional support is provided by ViiV Healthcare. 

A study looking at the safety and acceptability of adolescents assigned female at birth (HPTN 084-01) is expected to begin enrolling participants in August. HPTN 084-01 will enroll about 50 adolescents assigned female at birth. More information about HPTN 084-01 can be found at hptn.org/research/studies/084-01 

Results for both studies are expected in 2023.