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Pilot study on efficacy of a simplification strategy from DRV/r 600/100 mg BID to DRV/r 800/100mg QD + OBT in HIV-positive patients HAART-experienced with virological response. - DRV-xp

Pilot study on efficacy of a simplification strategy from DRV/r 600/100 mg BID to DRV/r 800/100mg QD + OBT in HIV-positive patients HAART-experienced with virological response. - DRV-xp

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-016705-42-IT
Enrollment
Unknown
Registered
2009-11-02
Start date
2009-11-10
Completion date
Unknown
Last updated
2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV infection MedDRA version: 12.0 Level: LLT Classification code 10020161 Term: HIV infection

Interventions

Trade Name: PREZISTA Pharmaceutical Form: Tablet INN or Proposed INN: DARUNAVIR CAS Number: 206361-99-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400-

Sponsors

ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - >18 years; - Confirmed HIV-infection; - Being on stable therapy with DRV/r 600/100mg BID + OBT from at least 6 months - CD4+ >100 cellule/L at starting HAART and CD4> 200 cell/ml at scrrening. - Confirmed HIV-1 RNA =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Previous virological failure (2 confirmed HIV-1 RNA VL>500 cp/ml) while on DRV/RTV-based therapy. - Previous evidence of >3 DRV-RAMS (resistance- associeted mutations) according with IAS-USA guidelines 2008 (V11I, V32I, L33F, I47V, I50V, I84V, I54M/L, T74P, L76V, L89V) - Intollerance to the drug used Contraindicated concomitant treatment - Subjects which in the opinion of the investigator is unable to complete the study period; - Laboratory alterations: o SGOT and SGPT &#8805;2,5 UNL; o creatinin >1,5 UNL; o ANC <1000/mm3; o Hb <10 g/dL; o PLT <75.000/mm3; - Clinically significant disease - Pregnancy

Design outcomes

Primary

MeasureTime frame
Main Objective: - Evaluate virological efficacy of a simplification strategy from DRV/r 600/100 mg BID to DRV/r 800/100mg QD + OBT in HIV-positive patients HAART-experienced with virological response.;Secondary Objective: - To evaluate safety and tolerability of DRV/r 800/100 mg in experienced-patients To evaluate and compare the subject-reported adherence and quality of life (QoL) at baseline and the evolution of adherence and QoL over 48 weeks; - To compare the antiretroviral drug treatment cost over 48 weeks;Primary end point(s): Percentage of subjects with < 40 cp/ml at Week 48—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026