Safety and tolerability of the ACE-inhibitor lisinopril among Nigerian adults with HIV: preliminary pilot data from a randomized clinical trial.

We report preliminary safety and tolerability data from 66 persons living with HIV (PLWH) (≥ 18 years old) who received escalating dosages of lisinopril or matched placebo, in addition to antiretroviral therapy in northern Nigeria. We monitored for adverse events (AEs) by reviewing patient history, laboratory data, and clinic data at each follow-up visit. We then characterized all AEs in terms of "relatedness" to study intervention and graded based on severity (1-5 grading scale) using the Division of AIDS Toxicity Grading Scale, version 2.1. For this study, we monitored 66 participants over 7 months. Among 33 participants on lisinopril, 14 (42.4%) remained on 5 mg/day while 19 (57.6%) tolerated ≥ 10 mg/day. Forty-one AEs occurred in 31 participants, with 19 (61.3%) on lisinopril. The majority, 37 (90.2%) of the AEs were Grade 1 or 2 in severity. Hypotension was most frequent in the Lisinopril group (4 (12.1%) vs. 2 (6.1%) in placebo), occurring at 10 mg. Persistent cough occurred in 3 (9.1%) Lisinopril recipients vs. 2 (6.1%) placebo, all at 5 mg. In 2 (66.7%) of the 3 Lisinopril recipients, the cough persisted leading to unblinding and a switch to Losartan. The most serious AE was angioedema that occurred in one participant receiving 5 mg Lisinopril, requiring unblinding and discontinuation. Transient kidney function worsening (eGFR < 60 mL/min/1.73 m2) occurred in one participant receiving Lisinopril and an elevation of serum creatinine occurred in 2 (6.1%) of Lisinopril recipients compared to 4 (12.1%) on placebo. All AEs resolved. In conclusion, we found a high level of safety and tolerability to lisinopril among PLWH enrolled in a clinical trial in Nigeria. This preliminary data will inform the development of effective data safety and monitoring plans for similar studies.