Status:
COMPLETED
Study to Evaluate Changes in CD4 on Replacing TDF With ABC or DDI+TDF With ABC+3TC
Lead Sponsor:
Hospital de Granollers
Conditions:
HIV Infections
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 do...
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 unadvi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00338390
Start Date
April 1 2005
End Date
February 1 2007
Last Update
March 24 2015
Active Locations (21)
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1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
2
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain, 08025
3
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain, 08036
4
Hospital Sant Jaume de Calella
Calella, Barcelona, Spain, 08370