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Completed

NCT Number: NCT00405925

FREE Study: Efficacy and Toxicity of Trizivir

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rijnstate Hospital

Arnhem, Gelderland, 6800 TA, Netherlands

About this study

The primary objective is to compare the antiviral efficacy of an early switch from a boosted PI/2NRTI regimen to Trizivir (after undetectability of HIV-RNA has been achieved on 2 consecutive occasions) with uninterrupted use of the PI/2NRTI regimen for 96 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Trizivir

Drug

zidovudine,lamivudine,abacavir

Drug

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

Primary outcomes

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

Secondary outcomes

  1. HIV-RNA <50 cop at week 96

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

  3. Time to virological failure

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

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

  6. Proportion of subjects experiencing one or more predefined values of fasting glucose and triglycerides, LDL and LDL/HDL ratio

  7. Development of adverse events

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Free Study: a Randomised, Open Label, Multicentre Strategic Study to Evaluate the Efficacy and Toxicity of an Early Switch From a PI-containing Regimen to Trizivir ® on Guidance of Viral Load in HIV-1 Infected , Antiretroviral naïve Adults

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Nov 30, 2006
Registry last updated
Jun 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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