CARES

Cabotegravir And Rilpivirine: Efficacy and Safety Study

FAQs

Frequently Asked Questions

For participants on injection treatment, they will be given additional access to the injectable drugs for additional two years after the end of their participation in the study. This is what is called Post-Trial Access (PTA). This access after the trial may be stopped for any of the following reasons;

  • If according to the medical provider, the participant is no longer deriving benefit from the injectable drugs. This may occur when their HIV viral load is not well controlled.
  • If the participant gets a condition that according to the study protocol, requires him/her to stop using the injectable drugs. This may happen because the participant need to take a medication that is not permitted to be used concurrently with injectable drugs or he/she develops a severe side effect to the drugs.
  • When injectable drugs development programs are terminated. In this case, the care provider will guide the participants on how to access other treatment options.
  • When the injectable drugs become registered and reimbursed in the country for public use. In this case, the care provider will guide participants on how to access treatment.

The current provision for PTA is only for participants receiving the injectable drugs during the study.

Majority of the side effects of the injectable drugs reported in previous studies are related to the injection site with injection site pain being the most reported. These side effects are majorly mild to moderate usually lasting for less than a week. Some of the side effects are listed below;

  • Injection site reactions (ISRs) such as pain, tenderness, erythema, etc.
  • Other non-ISRs include; headache, nausea, insomnia, dizziness, abnormal dreams, fatigue, and vomiting among others.

The current drug regimen used in the CARES study is meant to be administered every 2 months and therefore the interval between injections cannot be extended beyond 2 months.

This is one of the reasons why CARES study is being conducted in Sub-Saharan Africa, a low- or middle-income setting.

This is also one of the reasons for conducting CARES study

No. Once a patient is already receiving these injectable drugs, they are not required to take any oral ART. If you are a participant and not sure about taking your treatment, please contact your CARE provider.

The pain experienced during this injection is similar to that experienced from injecting any other drug in the buttock. However, the experience of the pain is relative to the individual but so far, we have noted that the pain is tolerable.

The injection is required to be given preferably in the anterolateral area of the buttocks which requires some training. Once trained it should be relatively easy to administer.

The injections are given separately because the two drugs are not co-formulated and therefore have to be given as different drugs. And we do not have any instructions/information for combining the two.

Firstly, the drugs have been extensively researched to see that they are safe and do not have fatal or very difficult side effects. If a person experiences side effects they are advised to seek medical attention as soon as possible.