HIV - Monotherapy in Switzerland (MOST-ch)

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cantonal Hospital of St. Gallen
• Collaborators: Swiss HIV Cohort Study; Swiss National Science Foundation
• Treatments: Lopinavir

Criteria

Inclusion Criteria:

• Age > 18 years.

• HIV seropositive.

• HAART (> 6 months) with at least 3 months successfully suppressed HIV- RNA (two most recent RNA measurements < 50 cp/ml). HAART is defined as either:

• 1 PI plus 2 NRTIs,

• 1 NNRTI plus 2 NRTIs, or

• 3 NRTIs.

• HIV-RNA in plasma < 50 cp/ml at screening.

• Stable antiretroviral therapy (unchanged drug combination) during the last four weeks.

• If not currently on a LPV/ r based therapy, willing to switch to LPV/ r bid therapy in case patient is randomized to the monotherapy arm

• Signed written informed consent.

• Highly motivated patients able to understand the investigational nature of this open observational study and willing to participate in additional procedures.

Exclusion Criteria:

• Other investigational substance or substances active against HIV.

• Previous history of adverse events with the drugs under investigation.

• Previous history of any virological treatment failure (does not include deliberate treatment interruption) or documented resistance against the drugs under investigation (LPV/r).

• Patient who has no effective alternative treatment options in case the study treatment fails (according to the physician's judgment).

• Pregnancy (negative pregnancy test for women of childbearing potential at screening).

• Active AIDS-defining disease necessitating antibiotic or chemotherapy at the time of screening.

• Chronic hepatitis B.