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Determinación de niveles plasmáticos e intracelulares de los inhibidores de la transcriptasa inversa análogos a nucleósidos (NRTI) y del análogo a nucleótido tenofovir disoproxil fumarato (TDF) en pacientes tratados con abacavir y/o lamivudina administrados con o sin TDF

Determinación de niveles plasmáticos e intracelulares de los inhibidores de la transcriptasa inversa análogos a nucleósidos (NRTI) y del análogo a nucleótido tenofovir disoproxil fumarato (TDF) en pacientes tratados con abacavir y/o lamivudina administrados con o sin TDF

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-000948-25-ES
Enrollment
50
Registered
2004-09-27
Start date
2004-10-01
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

HIV-infected patients

Interventions

Trade Name: Epivir® Pharmaceutical Form: Tablet INN or Proposed INN: lamivudina Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Trade Name: Ziagen® Pharmaceut

Sponsors

Fundació de Lluita Contra la Sida
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: HIV-infected patients >18 years old Indetectable viral load HAART receiving treatment during previous three months including lamivudine and/or ABC and TDF, with ritonavir/lopinavir or nevirapine 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: Interruption of the theraphy during the study Concomitant treatment with other medicinal products that should interaction with antirretroviral treatment Concomitant treatment with other antirretroviral drugs during the study

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate if the co-administration of tenofovir disoxipropil fumarate (TDF) modifies intracelular levels of abacavir (ABC) and lamivudine;Secondary Objective: To evaluate if the co-administration of tenofovir disoxipropil fumarate (TDF) modifies plamatic levels of abacavir (ABC) and lamivudine To evaluate the posible correlation between plasmatic and intracelular levels of NRTI and tenofovir disoxipropil fumarate (TDF);Primary end point(s): Variations of lamivudine and abacavir (ABC) intracelular levels before and after interruption of tenofovir disoxipropil fumarate (TDF) administration—

Countries

Spain

Outcome results

None listed

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