HIV - Monotherapy in Switzerland (MOST-ch)

NCT00531986 | Terminated Phase 4 DMC

• 2 other identifiers: SHCS-Projekt Nr.: 490SHCS 490
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

HIV Infections

Keywords

Monotherapy; Neuropsychological tests; HIV viral load in ZNS; HIV viral load in genital; Lumbar puncture and HIV viral load in ZNS; Monotherapy and compartment failure (ZNS and genital); ZNS viral load under monotherapy; Genital viral load under monotherapy; Neuropsychological tests (HIV Dementia); Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Failure in CNS

  Week 48

Secondary Outcomes (1)

• Predictors of failure

  week 48

Study Arms (2)

Monotherapy

EXPERIMENTAL

Ritonavir-boosted lopinavir (Kaletra®) will be used as monotherapy

Drug: Lopinavir-Monotherapy

Continued ART

ACTIVE COMPARATOR

Continuation Therapy, conventional triple HAART

Drug: HAART

Interventions

Lopinavir-Monotherapy DRUG

Patients on triple HAART will be switched to LPV/r-monotherapy

Also known as: Kaletra

Monotherapy

HAART DRUG

Patients will continued their current HAART

Also known as: Any ART

Continued ART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• PI plus 2 NRTIs,
• NNRTI plus 2 NRTIs, or
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead
• Swiss National Science Foundation: collaborator
• Swiss HIV Cohort Study: collaborator

Study Sites (6)

Flepp

Zurich, Bellariastrasse 38, 8038, Switzerland

Location

Furrer

Bern, INF KP PKT 2B Freiburgstr., 3010, Switzerland

Location

Nuesch

Basel, Petersgraben 4, 4031, Switzerland

Location

Cavassini

Lausanne, Rue Du Bugnon 21, 1005, Switzerland

Location

Opravil

Zurich, Rämistrasse 100, 8091, Switzerland

Location

Hirschel

Geneva, 1211, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 20802298 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

HIV Infections; AIDS Dementia Complex

Interventions

lopinavir-ritonavir drug combination; Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Officials

• Pietro Vernazza, Professor

  Swiss HIV Cohort Study

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Division Infectious Diseases

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 19, 2007
• Study Start: January 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

CH (6)