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STUDY TO EVALUATE THE EFFICACY, SAFETY AND ECONOMIC IMPACT OF REDUCING DOSES OF DARUNAVIR IN PATIENTS INFECTED WITH HIV TREATED WITH DARUNAVIR / RITONAVIR ONCE A DAY

CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY AND ECONOMIC IMPACT OF REDUCING DOSES OF DARUNAVIR IN PATIENTS INFECTED WITH HIV TREATED WITH DARUNAVIR / RITONAVIR ONCE A DAY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-006272-39-ES
Enrollment
Unknown
Registered
2012-02-10
Start date
2012-04-26
Completion date
Unknown
Last updated
2014-04-28

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

Conditions

HIV-infected patients on stable treatment with darunavir / ritonavir 800/100 mg qd plus two transcriptase inhibitors, nucleoside analogs for at least 4 weeks. MedDRA version: 14.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Prezista Pharmaceutical Form: Tablet CAS Number: 635728-49-3 Other descriptive name: DARUNAVIR ETHANOLATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number

Sponsors

Fundació Lluita contra la SIDA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Treatment stable with darunavir / ritonavir 800/100 mg qd plus two nucleoside analogs transcriptase inhibitors for at least 4 weeks. - HIV viral load in plasma =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - AIDS-defining disease in the previous 4 weeks. -Virologic failure history previous antiretroviral treatment regimens that included protease inhibitor drugs. - Presence of darunavir resistance mutations documented in previous genotypes.

Design outcomes

Primary

MeasureTime frame
Main Objective: Compare the proportion of patients maintaining HIV viral load in plasma 55 ng / mL 8.The patients who fail, to evaluate the incidence of new resistance mutations to antiretroviral drugs.;Primary end point(s): Compare the proportion of patients maintaining HIV viral load in plasma <50 copies / mL after 48 weeks of follow-up.;Timepoint(s) of evaluation of this end point: 48 weeks—

Secondary

MeasureTime frame
Timepoint(s) of evaluation of this end point: 4, 12, 24, 36 and 48 weeks;Secondary end point(s): 1. Compare the proportion of patients maintaining HIV viral load in plasma 55 ng / mL after 4, 12, 24, 36 and 48 weeks follow up. 8.The patients who fail, to evaluate the incidence of new resistance mutations to antiretroviral drugs.—

Countries

Spain

Contacts

Public ContactEnsayos Clínicos

Fundació Lluita contra la Sida

sgel@flsida.org+34934978849

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 19, 2026