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

NCT ID: NCT00338390

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2007-02-28

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 double replacement of tenofovir and ddI with abacavir + lamivudine (joint formulation) in a single daily dose to achieve these objectives.

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Maintain antiretroviral treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

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.

Group Type: EXPERIMENTAL

Abacavir

Intervention Type: DRUG

Change tenofovir to abacavir

Didanosine

Intervention Type: DRUG

Increase didanosine dose to 400 mg/day if weight is \> 60 Kg. or to 250mg/day if weight is \< 60 kg.

3

Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).

Group Type: EXPERIMENTAL

Abacavir+Lamivudine

Intervention Type: DRUG

Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).

Interventions

Abacavir

Change tenofovir to abacavir

Intervention Type: DRUG

Didanosine

Increase didanosine dose to 400 mg/day if weight is \> 60 Kg. or to 250mg/day if weight is \< 60 kg.

Intervention Type: DRUG

Abacavir+Lamivudine

Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).

Intervention Type: DRUG

Other Intervention Names

n/h.; n/h.; n/h.

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Granollers

OTHER

Sponsor Role: lead

Principal Investigators

Enric Pedrol, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundació Hospital de Granollers

Locations

Germans Trias i Pujol Hospital

Badalona, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

Hospital Sant Jaume de Calella

Calella, Barcelona, Spain

Hospital de Mataró

Mataró, Barcelona, Spain

Hospital Basurto

Bilbao, Bilabao, Spain

Hospital Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Sierrallana

Torrelavega, Cantabria, Spain

Hospital General de Castellón, , Castellón,

Castelló, Castello, Spain

H. del S.A.S. Jerez de la Frontera

Jerez de la Frontera, Cádiz, Spain

H. San Fco Borja Gandia

Gandia, Gandia, Spain

Hospital de Cabueñes

Gijón, Gijon, Spain

Hospital Clínico San Cecílio

Granada, Granada, Spain

Fundació Hospital de Granollers,

Barcelona, Granollers, Spain

Hospital Arquitecto Marcide

Ferrol, La Coruña, Spain

Fundación Jiménez Diaz

Madrid, Madrid, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Hospital Virgen Macarena

Seville, Sevilla, Spain

Hospital Joan XXIII

Tarragona, Tarragona, Spain

Hospital Arnau de Vilanova

Valencia, Valencia, Spain

Hospital Xeral de Vigo

Vigo, Vigo, Spain

Countries

Spain

Other Identifiers

2004-003749-42

Identifier Type: -

Identifier Source: secondary_id

EUROPA

Identifier Type: -

Identifier Source: org_study_id