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

This study has been completed.
Sponsor:
Information provided by:
Hospital de Granollers
ClinicalTrials.gov Identifier:
NCT00338390
First received: June 15, 2006
Last updated: October 30, 2008
Last verified: October 2008

June 15, 2006
October 30, 2008
April 2005
February 2007   (final data collection date for primary outcome measure)
Proportion of patients that increase their number of CD4 lymphocytes with regard to the baseline. [ Time Frame: At 12, 24, 36 and 48 weeks ] [ Designated as safety issue: No ]
Proportion of patients that increase their number of CD4 lymphocytes with regard to the baseline.
Complete list of historical versions of study NCT00338390 on ClinicalTrials.gov Archive Site
  • To evaluate the proportion of patients with viral load of HIV-1 <50 copies of the combinations studied during the follow-up period. [ Time Frame: At 12, 24, 36 and 48 weeks. ] [ Designated as safety issue: Yes ]
  • Incidence of new clinical adverse events that appear . [ Time Frame: during 48 weeks of follow-up ] [ Designated as safety issue: Yes ]
  • Evolution of the clinical adverse events that were already present at the time they were included in the study. [ Time Frame: during the 48 weeks of follow-up ] [ Designated as safety issue: Yes ]
  • Rate of treatment drop-outs due to the appearance of adverse events [ Time Frame: during the 48 weeks of follow-up ] [ Designated as safety issue: Yes ]
  • 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). [ Time Frame: during the follow-up period ] [ Designated as safety issue: Yes ]
  • Evolution of the laboratory alterations that were already present at the time they were included in the study. [ Time Frame: during the 48 weeks of follow-up ] [ Designated as safety issue: Yes ]
  • To evaluate the proportion of patients with viral load of HIV-1 <50 copies of the combinations studied during the follow-up period.
  • Incidence of new clinical adverse events that appear during follow-up.
  • Evolution of the clinical adverse events that were already present at the time they were included in the study.
  • Rate of treatment drop-outs due to the appearance of adverse events
  • 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).
  • Evolution of the laboratory alterations that were already present at the time they were included in the study.
Not Provided
Not Provided
 
Study to Evaluate Changes in CD4 on Replacing TDF With ABC or DDI+TDF With ABC+3TC
Study of Changes in CD4 Lymphocyte Count in Patients With a HAART Regimen Including DDI + Tenofovir and With Viral Suppression Following the Replacement of Tenofovir With Abacavir Once Daily or Following the Double Replacement of DDI + Tenofovir With Abacavir + Lamivudine in a Single Tablet

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Abacavir
    Change tenofovir to abacavir
    Other Name: n/h.
  • Drug: Didanosine
    Increase didanosine dose to 400 mg/day if weight is > 60 Kg. or to 250mg/day if weight is < 60 kg.
    Other Name: n/h.
  • Drug: Abacavir+Lamivudine
    Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).
    Other Name: n/h.
  • No Intervention: 1
    Maintain antiretroviral treatment
  • Experimental: 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.
    Interventions:
    • Drug: Abacavir
    • Drug: Didanosine
  • Experimental: 3
    Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).
    Intervention: Drug: Abacavir+Lamivudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
February 2007
February 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00338390
EUROPA, 2004-003749-42
No
Not Provided
Hospital de Granollers
Not Provided
Principal Investigator: Enric Pedrol, MD, PhD Fundació Hospital de Granollers
Hospital de Granollers
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP