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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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: TRIZIVIR (Drug); Non-nucleoside reverse transcriptase inhibitor (Drug); Boosted Protease Inhibitor (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

Official title: A Randomized, Open Label Study to Compare the Safety and Efficacy of a Long Term Maintenance With TRIZIVIR After a Switch From a Boosted PI or a NNRTI as First Line Therapy for 96 Weeks.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Principal outcome measures:

Proportion of patients with a HIV plasma RNA<50 copies/ml at 48 weeks

Secondary outcome:

Secondary outcomes measures:

proportion of patients with a HIV plasma RNA <50copies/ml at 96 weeks.

CD4 count profile at baseline 24 W,48 and 96 W

Genotypic profile resistance

determination of compliance of patient to treatment

Proportion of patients having a viral load <50 copies/mlL at 96 weeks in the ITT (M=F) population;

Proportion of patients with a virl load <50 copies/mL at 96 weeks (per protocol population)

Proportion of patients with a viral load <5 copies/mL at 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)

Patient adherence (using the PMAQ3 instrument); Retrospective determination of HLAB57 as a marker for hypersensitivity reaction in patients randomized to the Trizivir arm.

Quantitative measurement of the residual replicative capacity (using cell-based assay) using number of quiescent cells and quantification of proviral DNA.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.)

Locations and Contacts

GSK Clinical Trials Call Center, Angers 49000, France

GSK Clinical Trials Call Center, Bobigny 93000, France

GSK Clinical Trials Call Center, Bondy 93140, France

GSK Clinical Trials Call Center, Bordeaux 33075, France

GSK Clinical Trials Call Center, Brest 29200, France

GSK Clinical Trials Call Center, Clamart 92140, France

GSK Clinical Trials Call Center, Garches 92380, France

GSK Clinical Trials Call Center, Gonesse 95503, France

GSK Clinical Trials Call Center, La Roche sur Yon 85025, France

GSK Clinical Trials Call Center, La Rochelle 17000, France

GSK Clinical Trials Call Center, Lyon 69288, France

GSK Clinical Trials Call Center, Marseille 13006, France

GSK Clinical Trials Call Center, Nice 06202, France

GSK Clinical Trials Call Center, Orleans 45102, France

GSK Clinical Trials Call Center, Paris 75012, France

GSK Clinical Trials Call Center, Paris 75013, France

GSK Clinical Trials Call Center, Suresnes 92150, France

GSK Clinical Trials Call Center, Toulon 83056, France

GSK Clinical Trials Call Center, Toulouse 31052, France

GSK Clinical Trials Call Center, Toulouse 31059, France

GSK Clinical Trials Call Center, Vandoeuvre 54511, France

GSK Clinical Trials Call Center, Villeneuve Saint Georges 94190, France

Additional Information

Starting date: October 2004
Last updated: February 26, 2008

Page last updated: August 23, 2015

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