Trials Sponsors Conditions Drugs Pricing

Conditions

HIV Infections

Keywords

treatment experiencedHIV

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
+5 more secondary outcomes

Interventions

TRIZIVIRDrug

TRIZIVIR

Non-nucleoside reverse transcriptase inhibitorDrug

Non-nucleoside reverse transcriptase inhibitor

Boosted Protease Inhibitor

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

GlaxoSmithKline
Industrylead

MeSH Terms

Conditions

HIV Infections

Interventions

abacavir, lamivudine, and zidovudine drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency Syndromes

Study Officials

GSK Clinical Trials
GlaxoSmithKline
STUDY DIRECTOR

Enrollment

152 participants (actual enrollment reported by the registry).

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

Actual (reported)

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.)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record