Trials Sponsors Conditions Drugs Pricing

Conditions

HIV Infections

Keywords

HIV infectionDrug resistanceReverse transcriptase inhibitorNucleoside analoguetreatment experienced

Outcome Measures

Primary Outcomes (1)

Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W24
week 24

Secondary Outcomes (2)

Time to loss of virological response (TLOVR analysis; FDA algorithm) at W12, W24 and W48 (<50 copies/mL)
week 12, 24, and 48
Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W48
week 48

Study Arms (2)

1

EXPERIMENTAL

800mg BID apricitabine plus optimised background

Drug: apricitabine

2

ACTIVE COMPARATOR

150mg BID lamivudine plus optimised background

Drug: lamivudine

Interventions

apricitabineDrug

800mg BID apricitabine orally for 48 weeks

Also known as: AVX754

lamivudineDrug

150mg BID lamivudine orally for 48 weeks

Also known as: 3TC

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

HIV-1 positive with M184V/I mutation in reverse transcriptase;
years of age or older;

Sponsors & Collaborators

Avexa
Industrylead

Study Sites (100)

UAB, 845 19th St South, South Beville Biomedical Research Building

Birmingham, Alabama, 35294-2170, United States

University of Alabama at Birmingham

Birmingham, Alabama, 35294-2170, United States

Southwest Center for HIV/AIDS

Phoenix, Arizona, 85006, United States

Living Hope Clinical Foundation, Inc

Long Beach, California, 90813, United States

Kaiser Permanente Medical Center

San Francisco, California, 94115, United States

AIDS Research Alliance

West Hollywood, California, 90069, United States

Denver Health & Hospital Authority

MeSH Terms

Conditions

HIV Infections

Interventions

apricitabineLamivudine

Condition Hierarchy (Ancestors)

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

Study Officials

Susan W Cox, Ph D
Avexa Ltd
STUDY DIRECTOR
Michael Saag, MD
UAB Center for AIDS Research
PRINCIPAL INVESTIGATOR

Enrollment

239 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 30, 2008

First Posted

February 12, 2008

Study Start

February 2008

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (100)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (100)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations