NCT00338390

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at below P25 for phase_3 hiv-infections

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_3 hiv-infections

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

March 24, 2015

Status Verified

October 1, 2008

Enrollment Period

1.8 years

First QC Date

June 15, 2006

Last Update Submit

March 19, 2015

Conditions

HIV Infections

Keywords

AntiretroviralsCD4 cell counttoxicity

Outcome Measures

Primary Outcomes (1)

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

    At 12, 24, 36 and 48 weeks

Secondary Outcomes (6)

  • To evaluate the proportion of patients with viral load of HIV-1 <50 copies of the combinations studied during the follow-up period.

    At 12, 24, 36 and 48 weeks.

  • Incidence of new clinical adverse events that appear .

    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.

    during the 48 weeks of follow-up

  • Rate of treatment drop-outs due to the appearance of adverse events

    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).

    during the follow-up period

  • +1 more secondary outcomes

Study Arms (3)

1

NO INTERVENTION

Maintain antiretroviral treatment

2

EXPERIMENTAL

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: AbacavirDrug: Didanosine

3

EXPERIMENTAL

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

Drug: Abacavir+Lamivudine

Interventions

AbacavirDRUG

Change tenofovir to abacavir

Also known as: n/h.
2
DidanosineDRUG

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.
2
Abacavir+LamivudineDRUG

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

Also known as: n/h.
3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Sant Jaume de Calella

Calella, Barcelona, 08370, Spain

Location

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

Location

Hospital Basurto

Bilbao, Bilabao, 48013, Spain

Location

Hospital Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Sierrallana

Torrelavega, Cantabria, 39300, Spain

Location

Hospital General de Castellón, , Castellón,

Castelló, Castello, 12004, Spain

Location

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

Jerez de la Frontera, Cádiz, 11407, Spain

Location

H. San Fco Borja Gandia

Gandia, Gandia, 46700, Spain

Location

Hospital de Cabueñes

Gijón, Gijon, 33394, Spain

Location

Hospital Clínico San Cecílio

Granada, Granada, 18012, Spain

Location

Fundació Hospital de Granollers,

Barcelona, Granollers, 08400, Spain

Location

Hospital Arquitecto Marcide

Ferrol, La Coruña, 15405, Spain

Location

Fundación Jiménez Diaz

Madrid, Madrid, 28040, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Virgen Macarena

Seville, Sevilla, 41009, Spain

Location

Hospital Joan XXIII

Tarragona, Tarragona, 43007, Spain

Location

Hospital Arnau de Vilanova

Valencia, Valencia, 46015, Spain

Location

Hospital Xeral de Vigo

Vigo, Vigo, 36204, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

abacavirDidanosineabacavir, lamivudine drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

InosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Enric Pedrol, MD, PhD

    Fundació Hospital de Granollers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2006

First Posted

June 20, 2006

Study Start

April 1, 2005

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

March 24, 2015

Record last verified: 2008-10

Locations

ES(21)