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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00338390
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : March 24, 2015
Sponsor:
Information provided by:
Hospital de Granollers

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Abacavir Drug: Didanosine Drug: Abacavir+Lamivudine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
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.

Experimental: 3
Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).
Drug: Abacavir+Lamivudine
Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).
Other Name: n/h.




Primary Outcome Measures :
  1. 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 Measures :
  1. 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. ]
  2. Incidence of new clinical adverse events that appear . [ Time Frame: during 48 weeks of follow-up ]
  3. 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 ]
  4. Rate of treatment drop-outs due to the appearance of adverse events [ Time Frame: during the 48 weeks of follow-up ]
  5. 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 ]
  6. 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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00338390


Locations
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Sponsors and Collaborators
Hospital de Granollers
Investigators
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Principal Investigator: Enric Pedrol, MD, PhD Fundació Hospital de Granollers
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ClinicalTrials.gov Identifier: NCT00338390    
Other Study ID Numbers: EUROPA
2004-003749-42
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: October 2008
Keywords provided by Hospital de Granollers:
Antiretrovirals
CD4 cell count
toxicity
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine
Abacavir
Dideoxynucleosides
Didanosine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antimetabolites