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

NCT00449436 | Completed Phase 4

• 1 other identifier: 103441
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

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

Keywords

treatment experienced; HIV

Outcome Measures

Primary Outcomes (1)

• 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

  48 weeks

Secondary Outcomes (10)

• 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

  24, 48, 96 weeks

• Genotypic profile resistance

  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;

  up to 96 weeks

Interventions

TRIZIVIR DRUG

TRIZIVIR

Non-nucleoside reverse transcriptase inhibitor DRUG

Non-nucleoside reverse transcriptase inhibitor

Boosted Protease Inhibitor DRUG

Boosted Protease Inhibitor

Also known as: TRIZIVIR, Non-nucleoside reverse transcriptase inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

HIV Infections

Interventions

abacavir, lamivudine, and zidovudine drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2007
• First Posted: March 20, 2007
• Study Start: January 10, 2005
• Primary Completion: December 12, 2007
• Study Completion: December 13, 2007
• Last Updated: October 15, 2018

Record last verified: 2018-10