FREE Study: Efficacy and Toxicity of Trizivir

NCT00405925 | Completed Phase 3

• 1 other identifier: LTC-184-010403
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief Summary

Antiretroviral naïve patients with \<350 xE6/l CD4 cells and a HIV-viral load of \> 30.000 cop/ml are started on combivir ® and Kaletra ®. When patients have reached an undetectable viral load of\< 50 cop/ml on two consecutive occasions at least at week 12, but no later than week 24, they are randomised in either continuation with Combivir/Kaletra or switch to Trizivir ® twice daily one pill during 96 weeks. All patients randomised in the combivir/Kaletra arm are eligible to switch to Trizivir at any post randomisation visit when they reach predefined switch criteria for elevated levels of fasting glucose or lipids.

Conditions

HIV Infections

Keywords

AIDS; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• Plasma HIV-RNA < 400 cop/ml at week 96 for the Intent- To-Treat (ITT).

Secondary Outcomes (7)

• HIV-RNA <50 cop at week 96

• HIV-RNA <400 and <50 cop/ml at week 48

• Time to virological failure

• Immunological efficacy at week 48 and 96 measured by absolute change from baseline in CD4 cell counts

• Duration of change in CD4 cell count from baseline to >200,

Study Arms (2)

combivir/kaletra

ACTIVE COMPARATOR

All patients started with combivir/Kaletra and were randomized if they reached undetectable viral load (2 times) within 24 weeks into continuation of the same regimen or Trizivir (2 arms)

Drug: zidovudine,lamivudine,abacavir

Trizivir

EXPERIMENTAL

patients who reach undetectable HIV-RNA within 24 weeks are randomized to switch to trizivir or continuation of combivir/kaletra

Drug: Trizivir

Interventions

Trizivir DRUG

Trizivir

zidovudine,lamivudine,abacavir DRUG

zidovudine 300 mg bid, lamivudine 150mg bid, abacavir 300mg bid

combivir/kaletra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \>18 years of age, confirmed HIV-1 infection, never received antiretrovirals before, plasma-HIV-RNA \>30.000 cop/ml, CD4 \< 350 E6/l.

You may not qualify if:

• pregnancy, women using proven barrier methods of contraception, defined uncontrolled active AIDS defining complication, being on treatment for diabetes, other serious illnesses, expected non-compliance, defined laboratory abnormalities

Sponsors & Collaborators

• Rijnstate Hospital: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, 6800 TA, Netherlands

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

abacavir, lamivudine, and zidovudine drug combination; Zidovudine; abacavir, lamivudine drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Clemens Richter, MD

  Rijnstate Hospital, Arnhem, the Netherlands

  PRINCIPAL INVESTIGATOR

• P. Mulder

  Rijnstate Hospital, Arnhem, the Netherlands

  STUDY DIRECTOR

• N. Langebeek

  Rijnstate Hospital, Arnhem, the Netherlands

  STUDY DIRECTOR

• D. N. Burger

  Nijmegen, the Netherlands

  STUDY DIRECTOR

• P. P. Koopmans

  Nijmegen, the Netherlands

  STUDY DIRECTOR

• C. H. ten Napel

  Enschede, the Netherlands

  STUDY DIRECTOR

• P. H. Groeneveld

  Isala kliniek, Zwolle, the Netherlands

  STUDY DIRECTOR

• H. G. Sprenger

  Groningen, the Netherlands

  STUDY DIRECTOR

• R. W. ten Kate

  Haarlem, the Netherlands

  STUDY DIRECTOR

• M. E. van Kasteren

  Tilburg, the Netherlands

  STUDY DIRECTOR

• J. D. Le grand

  Charleroi, Belgium

  STUDY DIRECTOR

• R. Vriesendorp

  The Hague, the Netherlands

  STUDY DIRECTOR

• B. Bravenboer

  Eindhoven, the Netherlands

  STUDY DIRECTOR

• I. M. Hoepelman

  Utrecht, the Netherlands

  STUDY DIRECTOR

• P. van Bentum

  Rijnstate Hospital, Arnhem, the Netherlands

  STUDY DIRECTOR

• A. Smit-den Baars

  Rijnstate Hospital, Arnhem, the Netherlands

  STUDY DIRECTOR

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: November 29, 2006
• First Posted: November 30, 2006
• Study Start: March 1, 2003
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 2, 2010

Record last verified: 2010-05

Locations

NL (1)