- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00449436
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
Status
Completed
Conditions
Intervention / Treatment
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Viral Protease Inhibitors
- Protease Inhibitors
- Reverse Transcriptase Inhibitors
- HIV Protease Inhibitors
Other Study ID Numbers
- 103441
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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