Medication adherence in people living with HIV is crucial as daily regimens prevent the virus from multiplying and mutating. A late-stage trial investigating an ingestible sensor to monitor HIV medication adherence is set to start in the upcoming weeks, according to GlobalData’s Clinical Trials Database. GlobalData is the parent company of Clinical Trials Arena.
On the other hand, antiretroviral therapies (ARTs) potentially add the risk of kidney impairment in patients with HIV infection. While ARTs have lowered the rate of kidney disease, 30% of HIV-positive patients still have renal problems. Two trials are testing various drug combinations in people who are HIV-positive and measuring the effects on renal function.
Digital pill to monitor adherence
Fenway Health recently announced its plans to conduct a clinical trial investigating medication adherence with a next-generation ingestible sensor. The nonrandomised and open-label trial (NCT05592613) will enrol 30 patients who are HIV-negative and take Gilead Sciences’ Truvada, a pre-exposure prophylaxis (PrEP), and people with HIV (PWH) on Gilead Sciences’ Biktarvy, an antiretroviral therapy (ART).
The trial aims to investigate the use of the reader as a part of a digital pill system (DPS). The DPS comprises of an “ingestible radiofrequency emitter, integrated into a standard gelatine capsule, which then over-encapsulates the study medication (PrEP or ART)”, states the ClinicalTrials.gov listing. Once ingested, the chloride ions in the stomach activate the radiofrequency emitter and project a signal which is acquired by a wearable device, a wrist-borne reader, then stores and forwards data to a smartphone. This enables on-demand access to adherence data.
Digital pills help to monitor and potentially improve medication adherence, which is critical in patients with HIV in order to get the viral load to undetectable levels and avoid developing AIDS.
The trial is not yet recruiting, and the estimated primary outcome completion date is May 2023, according to ClinicalTrials.gov.
ART injections for HIV patients with renal disease
The Allegheny-Singer Research Institute (ASRI) will be investigating ViiV Healthcare’s Cabenuva as an intramuscular (IM) injection in patients with severe renal impairment. The single-group and open-label trial (NCT05601128) will enrol 12 participants with HIV infection.
The purpose of the study is to evaluate the safety, pharmacokinetics, and tolerability of Cabenuva, an ART combination regimen, in HIV patients with kidney disease compared to historical data observed in patients with normal renal function. The researchers hypothesise that intramuscular injection may be better tolerated and easier to take than regular oral medication.
Cabenuva, comprising cabotegravir (CAB) and rilpivirine (RPV), was approved in January 2021. CAB is an integrase enzyme inhibitor, which is necessary for viral DNA insertion into the host’s DNA. RPV is a diarylpyrimidine non-nucleoside reverse transcriptase inhibitor (NNRTI).
First, patients will receive a daily oral dose of CAB 30mg + RPV 25mg for at least 28 days. At the first month visit, patients will be dosed with CAB 600 mg + RPV 900 mg IM injections, followed by CAB 400mg + RPV 600mg IM injections monthly from the second until the fifth month. Starting the sixth month, participants will receive monthly doses of CAB 600mg + RPV 900mg IM injections until the twelfth month.
The ClinicalTrials.gov listing specified that this study received an FDA IND exemption as this is a pilot study and does not intend to change the product labelling.
The trial is estimated to start in January 2023 and complete the primary outcome by December 2024, according to ClinicalTrials.gov.
Switching ART in virologically suppressed PWH
Mahasarakham University in Thailand is recruiting 268 Thai PWH who are virologically suppressed and taking Gilead Sciences’ Atripla, a fixed-dose ART containing efavirenz, emtricitabine, and tenofovir disoproxil.
The study aims to evaluate the virologic and renal outcomes after switching from Atripla to fixed-dose combinations of tenofovir, lamivudine, and dolutegravir (TDF/3TC/DTG), also known as TLD, or dolutegravir and lamivudine (DTG/3TC).
The randomised and open-label trial (TCTR20221117001) will start in January 2023. The primary outcome will measure the glomerular filtration rate at 24 and 48 weeks. In the TLD active comparator arm, patients will receive a fixed daily oral dose of 50mg of DTG, 300mg of 3TC and 300mg of TDF. In the DTG/3TC arm, participants will receive a daily oral dose of 50mg DTG and 300mg of 3TC.
The study has not started recruitment. The anticipated study completion date is May 2024, according to the ThaiClinicalTrials.org listing.