Study to Evaluate Changes in CD4 on Replacing TDF With ABC or DDI+TDF With ABC+3TC
- Conditions
- HIV Infections
- Interventions
- Registration Number
- NCT00338390
- Lead Sponsor
- Hospital de Granollers
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Abacavir Change tenofovir to abacavir and increase didanosine dose to 400 mg/day if weight is \> 60 Kg. or to 250mg/day if weight is \< 60 kg. 2 Didanosine Change tenofovir to abacavir and increase didanosine dose to 400 mg/day if weight is \> 60 Kg. or to 250mg/day if weight is \< 60 kg. 3 Abacavir+Lamivudine Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).
- Primary Outcome Measures
Name Time Method Proportion of patients that increase their number of CD4 lymphocytes with regard to the baseline. At 12, 24, 36 and 48 weeks
- Secondary Outcome Measures
Name Time Method Incidence of new clinical adverse events that appear . during 48 weeks of follow-up To evaluate the proportion of patients with viral load of HIV-1 <50 copies of the combinations studied during the follow-up period. At 12, 24, 36 and 48 weeks. Evolution of the clinical adverse events that were already present at the time they were included in the study. during the 48 weeks of follow-up Rate of treatment drop-outs due to the appearance of adverse events 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). during the follow-up period Evolution of the laboratory alterations that were already present at the time they were included in the study. during the 48 weeks of follow-up
Trial Locations
- Locations (21)
Germans Trias i Pujol Hospital
🇪🇸Badalona, Barcelona, Spain
Hospital Sierrallana
🇪🇸Torrelavega, Santander, Spain
Hospital ClÃnic de Barcelona
🇪🇸Barcelona, Spain
Hospital ClÃnico San Carlos
🇪🇸Madrid, Spain
Hospital Arquitecto Marcide
🇪🇸El Ferrol, La Coruña, Spain
H. del S.A.S. Jerez de la Frontera
🇪🇸Jerez de la Frontera, Cádiz, Spain
H. San Fco Borja Gandia
🇪🇸Gandia, Spain
Hospital de Cabueñes
🇪🇸Gijon, Spain
Fundación Jiménez Diaz
🇪🇸Madrid, Spain
Hospital Xeral de Vigo
🇪🇸Vigo, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Joan XXIII
🇪🇸Tarragona, Spain
Hospital de Mataró
🇪🇸Mataro, Barcelona, Spain
Hospital Sant Jaume de Calella
🇪🇸Calella, Barcelona, Spain
Fundació Hospital de Granollers,
🇪🇸Barcelona, Granollers, Spain
Hospital Basurto
🇪🇸Bilbao, Bilabao, Spain
Hospital General de Castellón, , Castellón,
🇪🇸Castello, Spain
Hospital ClÃnico San CecÃlio
🇪🇸Granada, Spain
Hospital Marqués de Valdecilla
🇪🇸Santander, Spain