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

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Granollers
• Treatments: Abacavir; Didanosine; Dideoxynucleosides; Lamivudine; Tenofovir

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.