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
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