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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: TRIZIVIR; Drug: Non-nucleoside reverse transcriptase inhibitor; Drug: Boosted Protease Inhibitor	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	152 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	October 2004
Actual Primary Completion Date :	December 2007
Actual Study Completion Date :	December 2007

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Principal outcome measures:
2. Proportion of patients with a HIV plasma RNA<50 copies/ml at 48 weeks

Secondary Outcome Measures :

1. Secondary outcomes measures:
2. proportion of patients with a HIV plasma RNA <50copies/ml at 96 weeks.
3. CD4 count profile at baseline 24 W,48 and 96 W
4. Genotypic profile resistance
5. determination of compliance of patient to treatment
6. Proportion of patients having a viral load <50 copies/mlL at 96 weeks in the ITT (M=F) population;
7. Proportion of patients with a virl load <50 copies/mL at 96 weeks (per protocol population)
8. Proportion of patients with a viral load <5 copies/mL at 96 weeks
9. 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)
10. Patient adherence (using the PMAQ3 instrument); Retrospective determination of HLAB57 as a marker for hypersensitivity reaction in patients randomized to the Trizivir arm.
11. Quantitative measurement of the residual replicative capacity (using cell-based assay) using number of quiescent cells and quantification of proviral DNA.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.)

Contacts and Locations

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Locations

France
GSK Clinical Trials Call Center
Angers, France, 49000
GSK Clinical Trials Call Center
Bobigny, France, 93000
GSK Clinical Trials Call Center
Bondy, France, 93140
GSK Clinical Trials Call Center
Bordeaux, France, 33075
GSK Clinical Trials Call Center
Brest, France, 29200
GSK Clinical Trials Call Center
Clamart, France, 92140
GSK Clinical Trials Call Center
Garches, France, 92380
GSK Clinical Trials Call Center
Gonesse, France, 95503
GSK Clinical Trials Call Center
La Roche sur Yon, France, 85025
GSK Clinical Trials Call Center
La Rochelle, France, 17000
GSK Clinical Trials Call Center
Lyon, France, 69288
GSK Clinical Trials Call Center
Marseille, France, 13006
GSK Clinical Trials Call Center
Nice, France, 06202
GSK Clinical Trials Call Center
Orleans, France, 45102
GSK Clinical Trials Call Center
Paris, France, 75012
GSK Clinical Trials Call Center
Paris, France, 75013
GSK Clinical Trials Call Center
Suresnes, France, 92150
GSK Clinical Trials Call Center
Toulon, France, 83056
GSK Clinical Trials Call Center
Toulouse, France, 31052
GSK Clinical Trials Call Center
Toulouse, France, 31059
GSK Clinical Trials Call Center
Vandoeuvre, France, 54511
GSK Clinical Trials Call Center
Villeneuve Saint Georges, France, 94190

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00449436 History of Changes
Other Study ID Numbers:	101957; AZLF30008
First Posted:	March 20, 2007
Last Update Posted:	February 29, 2008
Last Verified:	February 2008

Keywords provided by GlaxoSmithKline:

HIV; treatment experienced

Additional relevant MeSH terms:

HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Protease Inhibitors	HIV Protease Inhibitors; Reverse Transcriptase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors