A Phase IIa Safety, Tolerability and Acceptability Study of an Investigational Injectable HIV Integrase Inhibitor, GSK1265744, for PrEP in HIV Uninfected Men and Women
What is HPTN 077?
HPTN 077 is a study being done to learn more about the safety and acceptability of a drug called cabotegravir (sometimes also referred to as GSK 1265744) when taken orally and injected by HIV uninfected men and women. The study product was provided by GlaxoSmithKline on behalf of ViiV Healthcare.
Who participated in the study?
HPTN 077 enrolled approximately 200 HIV-uninfected men and women in 8 cities: Rio de Janeiro, Brazil; Lilongwe, Malawi; Vulindlela and Soweto, South Africa; Chapel Hill, North Carolina; Los Angeles and San Francisco, California; and Washington, District of Columbia. To enroll in the study, participants had to be deemed low risk for HIV infection, at least 18 years old, and able to provide written informed consent. Enrollment in to the study is completed and follow-up is ongoing.
Why is HPTN 077 important?
HPTN 077 is an important next step in helping to determine if future research should be done to see if injectable cabotegravir can be used for pre-exposure prophylaxis (PrEP) in people at greater risk of acquiring HIV.
What happened during the study?
Study participants were randomly placed in one of two groups. One group was given pills and injections that had the cabotegravir in it. Approximately seventy-five percent of participants were in this group. The other group was given pills and injections that did not have cabotegravir in it. This is called a placebo. The placebo forms of the drug typically look like the active or “real” drug, but they do not have the drug or any other medicine in them. Approximately twenty-five percent of participants were in this group. The researchers and participants did not know who is getting active drug.
Participants were told that one of the best things they can do to protect themselves from getting HIV and other sexually transmitted infections (like gonorrhea, syphilis or chlamydia) was to use a condom every time they have sex.
Participants had approximately 19 – 22 study visits over the course of the entire study, which lasted for about two years. At these visits the participants received a physical exam, including checking to see the health of their heart, liver, bones and kidneys, and discussed any concerns or side effects that may be related to the study drugs. All participants received HIV testing and prevention counseling, as well as condoms at each study visit.
What were the results of the study?
HPTN 077 showed that cabotegravir:
- It is safe and well tolerated
- The dosing being used in HPTN 083 and HPTN 084 is supported by PK data from HPTN 077
- Cabotegravir is not associated with weight gain in HIV negative individuals
- Cabotegravir does not seem to have clinically significant interactions with hormonal contraception.
- The half-life is more prolonged in females compared to males, and longer for those with higher Body Mass Index
Photos provided by ViiV Healthcare
HPTN 077 Version 3.0
- HPTN 077 Protocol V3.0 - 13 Oct. 2015
- Version 3.0: Letter of Amendment #3 - 7 Nov 2016
- Version 3.0: Letter of Amendment #2 - 28 July 2016
- Version 3.0: Letter of Amendment #1 - 6 July 2016
HPTN 077 Version 2.0
- HPTN 077 Protocol V2.0 - 18 Nov 2014
- Version 2.0: Letter of Amendment #1 30 Mar 2015
- Version 2.0: Letter of Amendment #2 6 July 2015
- Version 2.0: Clarification Memo #1 - 4 Dec 2014
- Version 2.0: Clarification Memo #2 – 9 Feb 2015
HPTN 077 Version 1.0