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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Abacavir
Didanosine
Abacavir+Lamivudine
Sponsored by
Hospital de Granollers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Antiretrovirals, CD4 cell count, toxicity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Germans Trias i Pujol Hospital
  • Hospital Sant Jaume de Calella
  • Hospital de Mataró
  • Hospital Basurto
  • H. del S.A.S. Jerez de la Frontera
  • Fundació Hospital de Granollers,
  • Hospital Arquitecto Marcide
  • Hospital Sierrallana
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Clínic de Barcelona
  • Hospital General de Castellón, , Castellón,
  • H. San Fco Borja Gandia
  • Hospital de Cabueñes
  • Hospital Clínico San Cecílio
  • Fundación Jiménez Diaz
  • Hospital Clínico San Carlos
  • Hospital Marqués de Valdecilla
  • Hospital Virgen Macarena
  • Hospital Joan XXIII
  • Hospital Arnau de Vilanova
  • Hospital Xeral de Vigo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Maintain antiretroviral treatment

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 .
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.

Full Information

First Posted
June 15, 2006
Last Updated
March 19, 2015
Sponsor
Hospital de Granollers
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1. Study Identification

Unique Protocol Identification Number
NCT00338390
Brief Title
Study to Evaluate Changes in CD4 on Replacing TDF With ABC or DDI+TDF With ABC+3TC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital de Granollers

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Antiretrovirals, CD4 cell count, toxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Maintain antiretroviral treatment
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Arm Title
3
Arm Type
Experimental
Arm Description
Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).
Intervention Type
Drug
Intervention Name(s)
Abacavir
Other Intervention Name(s)
n/h.
Intervention Description
Change tenofovir to abacavir
Intervention Type
Drug
Intervention Name(s)
Didanosine
Other Intervention Name(s)
n/h.
Intervention Description
Increase didanosine dose to 400 mg/day if weight is > 60 Kg. or to 250mg/day if weight is < 60 kg.
Intervention Type
Drug
Intervention Name(s)
Abacavir+Lamivudine
Other Intervention Name(s)
n/h.
Intervention Description
Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).
Primary Outcome Measure Information:
Title
Proportion of patients that increase their number of CD4 lymphocytes with regard to the baseline.
Time Frame
At 12, 24, 36 and 48 weeks
Secondary Outcome Measure Information:
Title
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.
Title
Incidence of new clinical adverse events that appear .
Time Frame
during 48 weeks of follow-up
Title
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
Title
Rate of treatment drop-outs due to the appearance of adverse events
Time Frame
during the 48 weeks of follow-up
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enric Pedrol, MD, PhD
Organizational Affiliation
Fundació Hospital de Granollers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Germans Trias i Pujol Hospital
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Sant Jaume de Calella
City
Calella
State/Province
Barcelona
ZIP/Postal Code
08370
Country
Spain
Facility Name
Hospital de Mataró
City
Mataro
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain
Facility Name
Hospital Basurto
City
Bilbao
State/Province
Bilabao
ZIP/Postal Code
48013
Country
Spain
Facility Name
H. del S.A.S. Jerez de la Frontera
City
Jerez de la Frontera
State/Province
Cádiz
ZIP/Postal Code
11407
Country
Spain
Facility Name
Fundació Hospital de Granollers,
City
Barcelona
State/Province
Granollers
ZIP/Postal Code
08400
Country
Spain
Facility Name
Hospital Arquitecto Marcide
City
El Ferrol
State/Province
La Coruña
ZIP/Postal Code
15405
Country
Spain
Facility Name
Hospital Sierrallana
City
Torrelavega
State/Province
Santander
ZIP/Postal Code
39300
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General de Castellón, , Castellón,
City
Castello
ZIP/Postal Code
12004
Country
Spain
Facility Name
H. San Fco Borja Gandia
City
Gandia
ZIP/Postal Code
46700
Country
Spain
Facility Name
Hospital de Cabueñes
City
Gijon
ZIP/Postal Code
33394
Country
Spain
Facility Name
Hospital Clínico San Cecílio
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Fundación Jiménez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Joan XXIII
City
Tarragona
ZIP/Postal Code
43007
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Hospital Xeral de Vigo
City
Vigo
ZIP/Postal Code
36204
Country
Spain

12. IPD Sharing Statement

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

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