CompletedPhase 3

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

Spain75 participantsStarted 2005-04

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients that increase their number of CD4 lymphocytes with regard to the baseline.

Timeframe: At 12, 24, 36 and 48 weeks

Trial details

NCT IDNCT00338390

SponsorHospital de Granollers

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-02

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