HIV - Monotherapy in Switzerland (MOST-ch)

Summary

The investigators plan to conduct a two arm study, to compare failure rates in the central nervous system (CNS) and genital compartment in virologically fully suppressed patients continuing a highly active antiretroviral therapy (HAART) versus patients switching to ritonavir boosted lopinavir (Kaletra®) HIV-monotherapy. The study is composed of two phases of 48 weeks duration. In addition, neuropsychological tests (Color trial test A 1 and 2; Grooved pegboard; EWIA Digit Symbol form) and evaluation of side effects will be performed.

Timeline

Start

2007-01

Primary completion

2008-09

Completion

2008-12

Outcome

Missed primary endpoint

Stopped: “Unexpectedely high rates of treatment-failure”

paper Among failing patients, all five patients with a lumbar puncture had an elevated HIV RNA load in CSF PMID 20802298 ↗

Publications

• Gutmann C, Cusini A, Gunthard HF, Fux C, Hirschel B, Decosterd LA, Cavassini M, Yerly S, Vernazza PL; Swiss HIV Cohort Study (SHCS). Randomized controlled study demonstrating failure of LPV/r monotherapy in HIV: the role of compartment and CD4-nadir. AIDS. 2010 Sep 24;24(15):2347-54. doi: 10.1097/QAD.0b013e32833db9a1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lopinavir	Other / unclassified	—	—
Subject	Ritonavir	Other / unclassified	—	—

Indications