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Clinical Trials/EUCTR2011-006272-39-ES
EUCTR2011-006272-39-ES
Active, not recruiting
Not Applicable

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

Fundació Lluita contra la SIDA0 sitesFebruary 10, 2012
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ConditionsHIV-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: 14.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsPrezistaNorvir

Overview

Phase
Not Applicable
Intervention
Not specified
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.
Sponsor
Fundació Lluita contra la SIDA
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 10, 2012
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Fundació Lluita contra la SIDA

Eligibility 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 \<50 copies / mL for at least 12 weeks.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 112
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

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.

Outcomes

Primary Outcomes

Not specified

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