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

NCT ID: NCT00449436

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-10
• Study Completion Date: 2007-12-13

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

TRIZIVIR

TRIZIVIR

Intervention Type: DRUG

Non-nucleoside reverse transcriptase inhibitor

Non-nucleoside reverse transcriptase inhibitor

Intervention Type: DRUG

Boosted Protease Inhibitor

Boosted Protease Inhibitor

Intervention Type: DRUG

Other Intervention Names

TRIZIVIR; Non-nucleoside reverse transcriptase inhibitor

Eligibility 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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

103441

Identifier Type: -

Identifier Source: org_study_id