Infection with human immunodeficiency virus (HIV). MedDRA version: 14.1 Level: LLT Classification code 10008919 Term: Chronic HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Epivir
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LAMIVUDINE
CAS Number: 134678-17-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3
Sponsors
Fundació Lluita contra la SIDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV-1-infected subjects with age ?18 years old. 2. Receiving an antiretroviral therapy including NRTIs 3. Have a genotype before the start of the current antiretroviral regimen (if there is more than one genotupes availables, they will be added) documenting the existence of intermediate or complete resistance to one or more NRTIs, according to the criteria of the Spanish Network AIDS Research (ISR), this is? 3 score points. The presence of M184I/V indicates complete resistance to lamivudine or emtricitabine. In case of demonstrating complete resistance torwo NRTIs both drugs will be withdrawn simultaneously. 4. Receive at least two active drugs (sensitive) by the same algorithm, being one of them a boosted protease inhibitor. Is also considered as one active drug any NRTI that therefore can not be removed and will be maintained in the regime (eg, tenofovir). Raltegravir and enfuvirtide will be considered active if they are first used in the current regime. Maraviroc is considered active if it is documented R5 tropism before the start of the current regime and previously never failed to treatment with CCR5 antagonists. 5. The antiretroviral regimen must have been unchanged during the previous 6 moths. 6. Having a plasma HIV-1 RNA =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Chronic hepatitis B infection (defined as HBsAg positive), even with normal AST/ALT values. 2. Any active neoplasia or AIDS-defining event. 3. Pregnant or breastfeeding. 4. Patients with a history of poor adherence or poor adherence anticipated by discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and efficacy at 48 weeks of withdrawing NRTIs with intermediate or complete resistance in subjects with previous virological failure and a suppressed viral load for > 6 months.;Secondary Objective: ? To evaluate the proportion of patients free of virological failure (200 copies/mL). ? An observed-failure analysis will also be done, in which no imputation will be made for missing values unless the data were missing as a result of discontinuation because of lack of efficacy or the last value at discontinuation was a failure. ? To assess the incidence of adverse effects at 48 weeks.[22] ? To evaluate the changes in CD4 and CD8 cell counts at 48 weeks. ? To evaluate the cost of antiretroviral treatment in Euros at 48 weeks. ? The HIV-1 resistance selected in subjects with confirmed virological failure will also be analysed.;Primary end point(s): Proportion of subjects with plasma HIV-1 RNA < 50 copies/mL at 48 weeks. Treatment failure is defined as two consecutive HIV-1 RNA plasma levels above 50 copies/mL (measured at least 1 week apart) at week 48, or discontinuation of randomized treatment. Switches of treatment, including those carried out for reasons of toxicity, patients who had progression to AIDS or died, and lost of follow-up, are also classified as failures in this intention-to-treat analysis.;Timepoint(s) of evaluation of this end point: Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Time to confirmed virological failure (defined as a confirmed HIV-1 plasma viral load >200 copies/mL). ? Incidence of adverse events. ? CD4+ and CD8+ T-cell counts ? Plasma viral load ? Cost of antiretroviral treatment (?).;Timepoint(s) of evaluation of this end point: ? Time to confirmed virological failure (defined as a confirmed HIV-1 plasma viral load >200 copies/mL): from baseline to week 48 ? Incidence of adverse events at week 48. ? CD4+ and CD8+ T-cell counts at weeks 4, 16, 32 and 48. ? Plasma viral load at weeks 4, 16, 32 and 48. ? Cost of antiretroviral treatment (?) at week 48.. | — |
Countries
Spain
Contacts
Public ContactCRA
Fundació Lluita contra la SIDA
Outcome results
None listed