Eficacia virológica, inmunológica y trascendencia clínica del efecto de la lamivudina en pacientes portadores de la mutación M184V/I con fracaso terapéutico.
- Conditions
- HIV INFECTIO
- Registration Number
- EUCTR2005-000028-17-ES
- Lead Sponsor
- DAVID DALMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Age > or =18 years old.
Confirmed diagnosis of HIV-1 infection.
Sign informed consent.
Previous antiretroviral treatment must not be modified in the previous 3 months.
Viral load > 1000 copies/ml at the inclusion time.
Analysis of genotypic resistance with presence of M184V/I mutation.
Presence in genotypic test of M184V + 2 mutations to the following:
Nucleoside analog (M41L, D67N, K64R, K70R, L74V, V75I/T/M/S/A, L210W, T215Y/F, K219Q/E/N, Q151M, T69S, E44D, V118I).
Protease inhibitor (D30N, L33I/F/V, M46I/L, G48V, I50V/L, I54V, V82A/F/I/T/S, I84V, L90M).
No nucleoside analog (K103N, L100I, V106A, V108I, Y181C/I, Y188L, G190S/A).
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
Active infection in the previous month.
Pregnancy woman or women willing to be pregnant during the study.
Selection of lamivudine in the rescue treatment of the patient.
Inclusion of emtricitabine in the rescue treatment of the patient.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate virologic and inmunologic efficacy at 48 weeks of TARGA treatment with and without lamivudine in patients with HIV-1 infection and carriers of mutation M184V/I and failure of current antiretroviral treatment.;Secondary Objective: Evaluate clinic significance of lamivudine treatment in patients with HIV-1 infection carriers of mutation M184V/I: progression to AIDS and mortality.<br>Evaluate relation of antiretroviral treatment with lamivudine to appearance of new mutations regarding to basal genotype.<br>Evaluate rate of discordants answers: increase or maintenance of CD4 although virologic failure.<br>;Primary end point(s): Proportion of patients with viral load < 50 copies/ml at 24 and 48 weeks of randomization and start of rescue treatment. Change regards basal value in RNA-HIV-1 levels at 48 weeks of treatment.<br>Percentage of patients with viral load <50 copies/ml or decrease of viral load to 1 log at 48 weeks from start of treatment.<br>
- Secondary Outcome Measures
Name Time Method