Study to Evaluate Changes in CD4 on Replacing TDF With ABC or DDI+TDF With ABC+3TC

Hospital de Granollers75 enrolled

Overview

The study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir + ddI or whether it is better to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint formulation) in a single daily dose to achieve these objectives.

Different works have shown a high rate of virological failure among patients on abacavir + lamivudine + tenofovir or ddI + 3TC + tenofovir, thus rendering the use of these combinations actively unadvisable. Furthermore, recent studies have also shown that ABC+3TC are associated with a significantly higher increase in CD4 than the current treatment standard formed by AZT+3TC. This provides us with grounds to suppose that patients with TDF+ddI may recover their CD4 with ABC+3HT. Similarly, and recently, the existence of pharmacokinetic interactions between tenofovir + abacavir has begun to be questioned. Finally, the replacement of tenofovir with abacavir or tenofovir + ddI with abacavir + lamivudine does not detract from the potency of HAART, the toxicity profile is different and their behaviour at mitochondrial level is similar. This study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir + ddI or whether it is better to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint formulation) in a single daily dose to achieve these objectives.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

AbacavirDRUG

Change tenofovir to abacavir

DidanosineDRUG

Increase didanosine dose to 400 mg/day if weight is \> 60 Kg. or to 250mg/day if weight is \< 60 kg.

Abacavir+LamivudineDRUG

Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \> 18 years. * HIV-1 infected patients. * Patients on triple HAART therapy including ddI + tenofovir plus a PI or NNRTI for at least 3 months. * Patients with an undetectable HIV-1 viral load (\< 50 copies RNA / mL or \< centre's limit of detection) over the last 6 months. * Not be on treatment with immunosuppressives, such as: hydroxyurea, interferon, ribavirin or cytostatics. * Not be on treatment with interleukin-2 or other immunomodulators. * Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study. * Signature of the informed consent. Exclusion Criteria: * Incapacity to give informed consent. * Bad adherence or treatment interruptions over the previous 6 months. * Prior exposure to abacavir. * HAART Therapy including ddI at a dose of 400mg + tenofovir if weight \> 60 kg or ddI 250 mg + tenofovir if weight \< 60 kg. * Suspicion of cross resistances to abacavir and lamivudine. * Hepatic or pancreatic analytical alterations 4 times above the limit of normality. * Presence of opportunistic infections and/or recent tumours (\< 6 months). * Patients participating in another clinical trial.

Locations (21)

Germans Trias i Pujol Hospital

Badalona, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

Proportion of patients that increase their number of CD4 lymphocytes with regard to the baseline.

Time frame: At 12, 24, 36 and 48 weeks

Secondary Outcomes

To evaluate the proportion of patients with viral load of HIV-1 <50 copies of the combinations studied during the follow-up period.

Time frame: At 12, 24, 36 and 48 weeks.

Incidence of new clinical adverse events that appear .

Time frame: during 48 weeks of follow-up

Evolution of the clinical adverse events that were already present at the time they were included in the study.

Time frame: during the 48 weeks of follow-up

Rate of treatment drop-outs due to the appearance of adverse events

Time frame: during the 48 weeks of follow-up

Incidence of new laboratory alterations that appear during the follow-up period (change in renal parameters, changes in lactate levels, modification of pancreatic enzymes, changes in lipid parameters).

Time frame: during the follow-up period

Evolution of the laboratory alterations that were already present at the time they were included in the study.

Time frame: during the 48 weeks of follow-up

Data from ClinicalTrials.gov

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