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Phase IV-III, open-label, randomized, comparative study, to evaluate the safety and efficacy of the nucleoside supression of a triple therapy based on lopinavir-ritonavir vs. continuous triple therapy on patients infected by HIV that have maintained undetectable HIV viral load during 6 months. OK2004 - OK2004

Phase IV-III, open-label, randomized, comparative study, to evaluate the safety and efficacy of the nucleoside supression of a triple therapy based on lopinavir-ritonavir vs. continuous triple therapy on patients infected by HIV that have maintained undetectable HIV viral load during 6 months. OK2004 - OK2004

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-001323-37-ES
Enrollment
Unknown
Registered
2004-11-02
Start date
2004-11-29
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Infection by Human inmunideficiency virus

Interventions

Trade Name: KALETRA Product Name: Kaletra Soft Capsules Product Code: LPV/r Pharmaceutical Form: Capsule, soft INN or Proposed INN: Lopinavir CAS Number: 192725-17-0 Current Sponsor code: ABT-378 Conc

Sponsors

H. 12 de Octubre
Lead Sponsor
H. La Paz.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: .- HIV patients over 18 years old who are currently receiving treatment with two nucleosides (or 1 nuc + TDF) and Kaletra and with the confirmation of viral load less than 50 copies/ml during the six months previous to the inclusion in the study. At least two viral loads 50 copies/ml during the 6 months previous to the inclusion are required. .- Signed informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1.- Patients that have had a change of PI due to confirmed or suspected virological failure. 2.- Patients that are taking drugs which its association with Kaletra is contraindicated. 3.- Active drug adiction or psiquiatric disease that can interfere with the protocol compliance. Cannabis consumption or metadone treatment, as long as it is not interfering with adherence to the protocol according to investigators criteria, is excluded. 4.- Pregnancy or breastfeeding. In the case of women with childbearing potential, unless thy compromised to the use of an effective contraception method according to investigators criteria, during the whole study. 5.- If, in oppinion of the investigator, the patient is not likely to follow the protocol or he/she is unacceptable for any other reason. 6.- Patients with HepB surface antigen positive that are currently receiving treatment with tenofovir or lamivudine.

Design outcomes

Primary

MeasureTime frame
Main Objective: Efficacy of the supression of nucleosides from a triple therapy based on Lopinavir/Ritonavir, compared with the maintenance of the conventional triple therapy. ;Secondary Objective: .- Safety during 48 weeks. .- Resistance profile in patients with virological failure. .- Farmaeconomical analysis of the comparison of both strategies.;Primary end point(s): ARN HIV Viral load Efficacy endpoints: virologic failure Safety endpoints: therapeutic failure—

Countries

Spain

Outcome results

None listed

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