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
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ClinicalTrials.gov Identifier: NCT00449436 |
Recruitment Status
:
Completed
First Posted
: March 20, 2007
Last Update Posted
: February 29, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: TRIZIVIR Drug: Non-nucleoside reverse transcriptase inhibitor Drug: Boosted Protease Inhibitor | Phase 1 |
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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449436
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 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00449436 History of Changes |
Other Study ID Numbers: |
101957 AZLF30008 |
First Posted: | March 20, 2007 Key Record Dates |
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 |