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

October 11, 2018 updated by: GlaxoSmithKline

A Randomised, Open-Label Study to Evaluate the Efficacy and Safety of a Treatment Optimisation With Trizivir During 96 Weeks After a First Antiretroviral Treatment in HIV-1 Infected Subjects.

The current goal of antiretroviral therapy is to use a potent regimen that will suppress plasma viral load and maintain this suppression as long as possible. However, for most patients treated with such potent regimen, several problems can limit their long term effectiveness and contribute to incomplete viral suppression. These problems include poor tolerability, metabolic toxic effects. In order to avoid common problems as toxicity it might be interested to simplify treatment with fewer toxicity, lower pill burden. In this study we will evaluate the safety and efficacy of a simplification treatment with TRIZIVIR in long term after a Boosted PI or NNRTI containing regimen as first line therapy.

Study Overview

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Subject is ≥18 years of age and has documented evidence of HIV-1 infection.
  • Patient received first-line therapy including a boosted Protease Inhibitor or NNRTI for at least 6 months. Note: Only the patients whose first line antiretroviral treatment was modified for intolerance (and not for virological failure) could be included provided this treatment has been stable for at least 6 months.
  • Patient having a viral load < 50 copies/ml at screening and at least 3 months prior to enrollment,
  • Subject is willing and able to understand and provide written informed consent prior to participation in this study.
  • For women of childbearing potential: has a negative pregnancy test result (-human chorionic gonadotropin; -HCG) within 35 days prior to administration of investigational product (Day 1) and agrees to use a proven double barrier method of contraception or abstinence from 2 weeks before the first day of treatment.

Exclusion criteria:

  • Patient has received Trizivir®.
  • Patient has a viral load > 50 copies/mL at the screening and within 3 months of enrollment.
  • Patient has one or more CDC (1993) category C events in acute phase in classification of infection HIV.
  • Grade 3 ALT, AST (between 5 and 10 times normal higher limit) or Grade 4 (more than 10 times normal higher limit) for the during screening and before the first day of treatment (1-28 days);
  • Presence clinically-relevant of pancreatitis or hepatitis within 6 months of screening;
  • Patient has a severe hepatic insufficiency or a renal insufficiency in final stage.
  • Any situation (such as for example drug-addiction or active alcoholism) which, of the opinion of the investigator, could interfere with the observance and the evaluations required by the protocol and which could compromise the safety of the patient during his participation in the study;
  • Pregnancy, nursing, or pre-menopausal woman likely to be pregnant and not receiving reliable contraception (oral contraception, progesterone injectable associated a mechanical method of protection, intra-uterine device...) for the duration of study
  • Any biological anomaly for the period of the study and before the first day of treatment which, of the opinion of the investigator, could contra-indicate the participation of the patient in the study. Any biological anomaly of Grade 4 for the period of study and before the first day of treatment , except contrary opinion of the investigator and after agreement of the sponsor;
  • Any pathological state (diabetes, hyperthyroidism, syndrome of malabsorption, renal insufficiency...) which, of the opinion of the investigator, could interfere on absorption, the distribution, the metabolism and the excretion of the drugs;
  • Onset of allergy to the drugs of the study or other allergies which, of the opinion of the investigator, contra-indicates the participation of the patient in the study;
  • Patient is taking part in a clinical trial at the time of entry in the study except for observational trials.
  • Treatment by an experimental drug in the 30 days or five half-lives of the treatment (the longest period will be taken) which precede the first treatment of the test. (After opinion of the sponsor.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with a HIV plasma RNA<50 copies/ml at 48 weeks
Time Frame: 48 weeks
Proportion of patients with a HIV plasma RNA<50 copies/ml at 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with a HIV plasma RNA <50copies/ml at 96 weeks.
Time Frame: up to 96 weeks
Proportion of patients with a HIV plasma RNA <50copies/ml at 96 weeks
up to 96 weeks
CD4 count profile at baseline 24 W,48 and 96 W
Time Frame: 24, 48, 96 weeks
CD4 count profile at baseline 24,48, and 96 weeks
24, 48, 96 weeks
Genotypic profile resistance
Time Frame: up to 96 weeks
Genotypic profile resistance
up to 96 weeks
Determination of compliance of patient to treatment
Time Frame: up to 96 weeks
Determination of compliance of patient to treatment
up to 96 weeks
Proportion of patients having a viral load <50 copies/mlL at 96 weeks in the ITT (M=F) population;
Time Frame: up to 96 weeks
Proportion of patients having a viral load <50 copies/mlL at 96 weeks in the ITT (M=F) population
up to 96 weeks
Proportion of patients with a virl load <50 copies/mL at 96 weeks (per protocol population)
Time Frame: up to 96 weeks
Proportion of patients with a viral load <50 copies/mL at 96 weeks (per protocol population)
up to 96 weeks
Proportion of patients with a viral load <5 copies/mL at 96 weeks
Time Frame: up to 96 weeks
Proportion of patients with a viral load <5 copies/mL at 96 weeks
up to 96 weeks
Change from baseline in CD4 counts at 24, 48, 96 weeks; Genotypic resistance profile of the HIV-1 in the event of virological failure CV >1000 copies/mL, as confirmed twice; Time to virologic failure (by Kaplan - Meier)
Time Frame: 24, 48, 96 weeks
Change from baseline in CD4 counts at 24, 48, 96 weeks; Genotypic resistance profile of the HIV-1 in the event of virological failure CV >1000 copies/mL, as confirmed twice; Time to virologic failure (by Kaplan - Meier)
24, 48, 96 weeks
Patient adherence (using the PMAQ3 instrument); Retrospective determination of HLAB57 as a marker for hypersensitivity reaction in patients randomized to the Trizivir arm.
Time Frame: up to 96 weeks
Patient adherence (using the PMAQ3 instrument); Retrospective determination of HLAB57 as a marker for hypersensitivity reaction in patients randomized to the Trizivir arm.
up to 96 weeks
Quantitative measurement of the residual replicative capacity (using cell-based assay) using number of quiescent cells and quantification of proviral DNA.
Time Frame: up to 96 weeks
Quantitative measurement of the residual replicative capacity (using cell-based assay) using number of quiescent cells and quantification of proviral DNA.
up to 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2005

Primary Completion (Actual)

December 12, 2007

Study Completion (Actual)

December 13, 2007

Study Registration Dates

First Submitted

March 19, 2007

First Submitted That Met QC Criteria

March 19, 2007

First Posted (Estimate)

March 20, 2007

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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