Latitude A5359: To see if long-acting, injectable ARTs are helpful for people who are not adherent to daily pills

 in Clinical Trials / People Living With HIV  tagged non-adherent / People Living With HIV by

Protocol Summary:

This study will compare the use of long-acting, injectable anti-HIV medicines with anti-HIV medicines in daily pill form for people living with HIV who have not been previously adherent (keeping up) with their anti-HIV medicines in daily pill form.

Purpose of This Study:

Anti-HIV medicines taken as pills have been very successful in helping many people living with HIV to reduce their HIV viral load to very low amounts. Once these amounts get low enough, we say that the viral loads are undetectable. However, some people have not been able to take daily pills enough to get their viral loads to undetectable.

A new way of taking anti-HIV medicines has been developed. This new way, which is still in clinical trials, is giving the medicines as an injection or a shot, instead of as pills. The anti-HIV medicines given by injection last in the body for a much longer time than pills. Instead of a pill taken every day, these medicines are given by an injection once a month. This new way of giving anti-HIV medicines is called “long-acting, injectable antiretroviral therapy or LA ART”.

This study is looking at whether LA ART will be more successful for people who have not been adherent to their HIV medications when taking them in daily pill form. Taking the medicines in daily pill form is the current standard of care (SOC).

Requirements to Enter study:

The complete list of inclusion/exclusion criteria are in the protocol, including exclusionary medications. Below is an abbreviated list of the requirements.

Inclusion:

  • People living with HIV, 18 years of age and older.
  • Prescribed anti-HIV medicines for at least 6 months.
  • Has an HIV viral load greater than 200 copies at the screening visit.
  • Women must not be pregnant, planning to become pregnant, or breastfeeding. Women who can become pregnant must agree to use one form of effective birth control.
  • There is evidence of non-adherence to their HIV medications.

Non-adherence to HIV medications will be defined as having one of the two criteria below:

  1. Poor virologic response within the last 18 months for people who have been prescribed ART for at least 6 consecutive months.
  2. Lost to clinical follow-up within the last 18 months with ART non-adherence for 6 consecutive months or more. Lost to clinical follow-up is defined as either no contact with provider or missed 2 or more appointments in a 6-month period. ART non-adherence is defined as a lapse in ART 7 or more days (consecutive or non-consecutive), in the 6-month period where they were lost to clinical follow-up per participant report.

Exclusion:

  • Previous use of rilpivirine or cabotegravir.
  • Uncontrolled seizures.
  • Advanced liver disease.
  • Unwilling to receive injections in the buttocks.
  • Chronic Hepatitis C with planned or anticipated use of anti-HCV therapy prior to the end of step 2.
  • Active Hepatitis B infection.

Duration of Study:

The study lasts 120–180 weeks.

Compensation Provided

Further details in this PDF A5359 participantsumm IRB approved
and at https://clinicaltrials.gov/ct2/show/NCT03635788