MedDataX Logo

FREE Study: Efficacy and Toxicity of Trizivir

NCT ID: NCT00405925

Last Updated: 2010-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study To Evaluate Long Term Maintenance With TRIZIVIR After Boosted Protease Inhibitor (PI) Or Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) In HIV-1 Infected Adults

NCT00449436

HIV Infections
COMPLETED PHASE4

A Dose-Frequency Trial of Oral Retrovir in Patients With AIDS or Severe ARC

NCT00002046

HIV Infections
COMPLETED NA

Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients

NCT00234910

HIV Infection
COMPLETED PHASE3

TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients

NCT00110877

HIV Infection
COMPLETED PHASE3

A Study of 1592U89 Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs

NCT00002364

HIV Infections
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

combivir/kaletra

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)

Group Type ACTIVE_COMPARATOR

zidovudine,lamivudine,abacavir

Intervention Type DRUG

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

Trizivir

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

Group Type EXPERIMENTAL

Trizivir

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trizivir

Intervention Type DRUG

zidovudine,lamivudine,abacavir

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Rijnstate Hospital

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clemens Richter, MD

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital, Arnhem, the Netherlands

P. Mulder

Role: STUDY_DIRECTOR

Rijnstate Hospital, Arnhem, the Netherlands

N. Langebeek

Role: STUDY_DIRECTOR

Rijnstate Hospital, Arnhem, the Netherlands

D. N. Burger

Role: STUDY_DIRECTOR

Nijmegen, the Netherlands

P. P. Koopmans

Role: STUDY_DIRECTOR

Nijmegen, the Netherlands

C. H. ten Napel

Role: STUDY_DIRECTOR

Enschede, the Netherlands

P. H. Groeneveld

Role: STUDY_DIRECTOR

Isala kliniek, Zwolle, the Netherlands

H. G. Sprenger

Role: STUDY_DIRECTOR

Groningen, the Netherlands

R. W. ten Kate

Role: STUDY_DIRECTOR

Haarlem, the Netherlands

M. E. van Kasteren

Role: STUDY_DIRECTOR

Tilburg, the Netherlands

J. D. Le grand

Role: STUDY_DIRECTOR

Charleroi, Belgium

R. Vriesendorp

Role: STUDY_DIRECTOR

The Hague, the Netherlands

B. Bravenboer

Role: STUDY_DIRECTOR

Eindhoven, the Netherlands

I. M. Hoepelman

Role: STUDY_DIRECTOR

Utrecht, the Netherlands

P. van Bentum

Role: STUDY_DIRECTOR

Rijnstate Hospital, Arnhem, the Netherlands

A. Smit-den Baars

Role: STUDY_DIRECTOR

Rijnstate Hospital, Arnhem, the Netherlands

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LTC-184-010403

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients
NCT00056641 COMPLETED PHASE2
A Study to Determine the Antiviral Activity of TMC310911 When Administered With Ritonavir in Treatment-Naive Human Immunodeficiency Virus - Type 1 (HIV-1) Infected Patients
NCT00838162 COMPLETED PHASE2
Efficacy and Safety of Kaletra Monotheraphy Compared to Kaletra Based Triple Therapy to Treat HIV in Antiretroviral Naїve Patients
NCT00234923 COMPLETED PHASE3
TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients
NCT00896051 COMPLETED PHASE2
HIV-1 Infection Study of Once a Day Versus Twice a Day Protease Inhibitor in Antiretroviral Treatment Naive Adults
NCT00450580 COMPLETED PHASE3
Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection
NCT00440947 COMPLETED PHASE3
Study to Evaluate the Effectiveness of ABC+3TC +EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients
NCT00318123 COMPLETED PHASE3
Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients With AIDS or Advanced ARC
NCT00002020 COMPLETED NA
Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir
NCT00458302 COMPLETED PHASE3
A Randomised Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir (TPV) Plus 100 mg or 200 mg Ritonavir (RTV) p.o. BID in Comparison to 400 mg Lopinavir (LPV) Plus 100 mg RTV p.o. BID in Combination With Standard Background Regimen in ARV Therapy naïve Patients.
NCT00144105 TERMINATED PHASE2
Ambispective Cohort Study to Evaluate the Efficacy, Safety, and Tolerance of an Antiretroviral Regimen With Doravirine
NCT05140603 UNKNOWN
ROCKET I - Randomized Open Label Switch for Cholesterol Elevation on Kivexa Evaluation Trial
NCT00615810 COMPLETED PHASE4
Antiretroviral Treatment Simplification Study With Efavirenz + Abacavir + 3TC Once Daily
NCT00314626 COMPLETED PHASE3
Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)
NCT00054717 COMPLETED PHASE3
Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients
NCT00530920 COMPLETED PHASE2
A Study of Amprenavir in HIV-Infected Patients
NCT00002405 COMPLETED NA
Efficacy, Safety, and ToLerability of Switching to A Two-Drug Regimen With DTG/3TC Compared to Maintaining A Three-Drug REgimen With BIC/FTC/TAF or DTG/3TC/ABC in ViroLogically SupprEssed PeopLe Living With HIV After 24 and 48 Weeks of Follow-Up
NCT07138144 RECRUITING PHASE4
PK of Tenofovir, Emtricitabine and Efavirenz in Healthy Volunteers
NCT01108926 COMPLETED PHASE1
Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)
NCT00144170 COMPLETED PHASE3
TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients
NCT00071097 COMPLETED PHASE2
Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens
NCT00052117 COMPLETED PHASE2
Kaletra-isentress Treatment Evaluation
NCT00700115 COMPLETED PHASE4
Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir
NCT02104700 COMPLETED PHASE2/PHASE3
A Study to Assess Effectiveness and Safety of Fixed Dose Combination of Lopinavir/Ritonavir (LPV/r) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Patients After Switching From Kaletra in the Routine Clinical Settings of Russian Federation
NCT04138199 TERMINATED
The Pharmacokinetics of Double Boosted Protease Inhibitors in Antiretroviral-naive HIV-1 Infected Patients
NCT00400738 COMPLETED PHASE2