Study to Evaluate Changes in CD4 on Replacing TDF With ABC or DDI+TDF With ABC+3TC
Information source: Hospital de Granollers
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Abacavir (Drug); Didanosine (Drug); Abacavir+Lamivudine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Hospital de Granollers Official(s) and/or principal investigator(s): Enric Pedrol, MD, PhD, Principal Investigator, Affiliation: Fundació Hospital de Granollers
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.
Clinical Details
Official title: Study of Changes in CD4 Lymphocyte Count in Patients With a HAART Regimen Including DDI + Tenofovir and With Viral Suppression Following the Replacement of Tenofovir With Abacavir Once Daily or Following the Double Replacement of DDI + Tenofovir With Abacavir + Lamivudine in a Single Tablet
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion of patients that increase their number of CD4 lymphocytes with regard to the baseline.
Secondary outcome: To evaluate the proportion of patients with viral load of HIV-1 <50 copies of the combinations studied during the follow-up period.Incidence of new clinical adverse events that appear . Evolution of the clinical adverse events that were already present at the time they were included in the study. Rate of treatment drop-outs due to the appearance of adverse events 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). Evolution of the laboratory alterations that were already present at the time they were included in the study.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Hospital Clínic de Barcelona, Barcelona 08036, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona 08025, Spain
Hospital General de Castellón, , Castellón,, Castello 12004, Spain
H. San Fco Borja Gandia, Gandia 46700, Spain
Hospital de Cabueñes, Gijon 33394, Spain
Hospital Clínico San Cecílio, Granada 18012, Spain
Fundación Jiménez Diaz, Madrid 28040, Spain
Hospital Clínico San Carlos, Madrid 28040, Spain
Hospital Marqués de Valdecilla, Santander 39008, Spain
Hospital Virgen Macarena, Sevilla 41009, Spain
Hospital Joan XXIII, Tarragona 43007, Spain
Hospital Arnau de Vilanova, Valencia 46015, Spain
Hospital Xeral de Vigo, Vigo 36204, Spain
Germans Trias i Pujol Hospital, Badalona, Barcelona 08916, Spain
Hospital Sant Jaume de Calella, Calella, Barcelona 08370, Spain
Hospital de Mataró, Mataro, Barcelona 08304, Spain
Hospital Basurto, Bilbao, Bilabao 48013, Spain
H. del S.A.S. Jerez de la Frontera, Jerez de la Frontera, Cádiz 11407, Spain
Fundació Hospital de Granollers,, Barcelona, Granollers 08400, Spain
Hospital Arquitecto Marcide, El Ferrol, La Coruña 15405, Spain
Hospital Sierrallana, Torrelavega, Santander 39300, Spain
Additional Information
Starting date: April 2005
Last updated: March 19, 2015
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