A Phase 3 interventional study of Abacavir and Didanosine in HIV Infections, sponsored by Hospital de Granollers. Completed at 21 sites in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-03-24.
Sponsored by Hospital de Granollers · Phase 3, Interventional, and Treatment
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 75 is close to the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Hospital de Granollers is the lead sponsor of 27 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Maintain antiretroviral treatment
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.
Drug: Abacavir · Drug: Didanosine
Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).
Drug: Abacavir+Lamivudine
Change tenofovir to abacavir
Also known as: n/h.
Increase didanosine dose to 400 mg/day if weight is \> 60 Kg. or to 250mg/day if weight is \< 60 kg.
Also known as: n/h.
Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).
Also known as: n/h.
Proportion of patients that increase their number of CD4 lymphocytes with regard to the baseline.
Time frame: At 12, 24, 36 and 48 weeks
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
This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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Hospital de Granollers