Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients

Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients

Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in Patients With HIV. Influence on Morphological and Metabolic Disorders. A Randomized, Open-Label Multicenter Trial.

Rigshospitalet, Denmark, Hvidovre University Hospital, Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital, Abbott

Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV infected individuals. However an increasing number of HIV-patients have developed metabolic and morphological alterations including peripheral lipoatrophy. There is limited knowledge about lipodystrophic adverse events in nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens. The hypothesis is that nucleoside analogues are responsible for development of lipoatrophy, and, patients receiving an NRTI-sparing regimen will have little risk of peripheral lipoatrophy. The researchers plan to perform a randomized study recruiting 100 antiretroviral naive patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a protease-inhibitor sparing regimen. The main endpoint is changes in peripheral fat mass as determined by dual energy X-ray absortiometry (DEXA)-scanning.

Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination

Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24, 48 and 96

Compliance - proportion of patients who report to take 90%, respectively 95% of their medications at week 4, 48 and 96

Inclusion Criteria: Antiretroviral naïve patients HIV-1 infection as documented by a licensed HIV-1 antibody ELISA. Fulfilling the criteria for starting antiretroviral therapy. Ability to understand and provide written informed consent. Exclusion Criteria: Women being pregnant or breast-feeding. Fertile women using no safe contraception. Patients with active intravenous drug use. Abuse of alcohol, which in the opinion of the treating physician will reduce the patient´s ability to follow a therapeutic regimen and evaluations of the protocol. Ongoing medical treatment, which has a clinically significant interaction with lopinavir, ritonavir or efavirenz. Creatinine > 200 mmol/l. ALT or AST > 5 times upper normal value (200U/l).

Mathiesen IH, Salem M, Gerstoft J, Gaardbo JC, Obel N, Pedersen C, Ullum H, Nielsen SD, Hansen AE. Complete manuscript Title: Changes in RANKL during the first two years after cART initiation in HIV-infected cART naive adults. BMC Infect Dis. 2017 Apr 11;17(1):262. doi: 10.1186/s12879-017-2368-y.