HIV InfectionsPhase 4NCT00449436
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
A Phase 4 study testing TRIZIVIR, Non-nucleoside reverse transcriptase inhibitor and Boosted Protease Inhibitor in people with HIV Infections, run by GlaxoSmithKline.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- TRIZIVIR, Non-nucleoside reverse transcriptase inhibitor and Boosted Protease Inhibitor
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2005to 13 Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.)
About this study
Official title: 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.
- Conditions
- HIV Infections
- Being tested
- TRIZIVIR, Non-nucleoside reverse transcriptase inhibitor, Boosted Protease Inhibitor
- Keywords
- treatment experienced, HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIZIVIRDrug
TRIZIVIR
Non-nucleoside reverse transcriptase inhibitorDrug
Non-nucleoside reverse transcriptase inhibitor
Boosted Protease InhibitorDrug
Also called TRIZIVIR, Non-nucleoside reverse transcriptase inhibitor
Boosted Protease Inhibitor
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a HIV plasma RNA<50 copies/ml at 48 weeks
Proportion of patients with a HIV plasma RNA<50 copies/ml at 48 weeks
Measured: 48 weeks
Secondary outcomes (10)
Proportion of patients with a HIV plasma RNA <50copies/ml at 96 weeks.
Proportion of patients with a HIV plasma RNA <50copies/ml at 96 weeks
Measured: up to 96 weeks
CD4 count profile at baseline 24 W,48 and 96 W
CD4 count profile at baseline 24,48, and 96 weeks
Measured: 24, 48, 96 weeks
Genotypic profile resistance
Genotypic profile resistance
Measured: up to 96 weeks
Determination of compliance of patient to treatment
Determination of compliance of patient to treatment
Measured: up to 96 weeks
Proportion of patients having a viral load <50 copies/mlL at 96 weeks in the ITT (M=F) population;
Proportion of patients having a viral load <50 copies/mlL at 96 weeks in the ITT (M=F) population
Measured: up to 96 weeks
Proportion of patients with a virl load <50 copies/mL at 96 weeks (per protocol population)
Proportion of patients with a viral load <50 copies/mL at 96 weeks (per protocol population)
Measured: up to 96 weeks
Proportion of patients with a viral load <5 copies/mL at 96 weeks
Proportion of patients with a viral load <5 copies/mL at 96 weeks
Measured: 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)
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)
Measured: 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.
Patient adherence (using the PMAQ3 instrument); Retrospective determination of HLAB57 as a marker for hypersensitivity reaction in patients randomized to the Trizivir arm.
Measured: 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.
Quantitative measurement of the residual replicative capacity (using cell-based assay) using number of quiescent cells and quantification of proviral DNA.
Measured: up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
- Study start10 Jan 2005
- Primary completion12 Dec 2007
- Study completion13 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449436
- Sponsor's protocol ID
- 103441
- Status last verified
- Oct 2018
- First submitted
- 19 Mar 2007
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00449436
- Acronym / sponsor ID
- 103441
- Conditions
- HIV Infections
- Keywords
- treatment experienced, HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2005 (actual)
- Primary completion
- 12 Dec 2007 (actual)
- Study completion
- 13 Dec 2007 (actual)
- First posted
- 20 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRIZIVIRTRIZIVIR | Drug | – |
| Non-nucleoside reverse transcriptase inhibitorNon-nucleoside reverse transcriptase inhibitor | Drug | – |
| Boosted Protease InhibitorAlso: TRIZIVIR, Non-nucleoside reverse transcriptase inhibitorBoosted Protease Inhibitor | Drug | – |
Primary outcome
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
10 secondary outcomes
Proportion of patients with a HIV plasma RNA <50copies/ml at 96 weeks.
Time frame: up to 96 weeks
CD4 count profile at baseline 24 W,48 and 96 W
Time frame: 24, 48, 96 weeks
Genotypic profile resistance
Time frame: up to 96 weeks
Determination of compliance of patient to treatment
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;
Time frame: 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 <5 copies/mL at 96 weeks
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
Related trials for HIV Infections
Not yet recruitingPhase 1
huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers
Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
Enrolling by invitation
Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection
HIV Infections
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
Not yet recruitingPhase 4
Study of BIC/LEN FDC Versus Stable Baseline Regimens in Virologically Suppressed People With HIV
HIV-1 Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TRIZIVIR, Non-nucleoside reverse transcriptase inhibitor and Boosted Protease Inhibitor in people with HIV Infections, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a HIV plasma RNA<50 copies/ml at 48 weeks (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.