NCT00126880

Brief Summary

The study will measure how safe and effective AVX754 (a new drug for the treatment of HIV) is in treating HIV-1 infected people who have failed treatment with lamivudine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

2.5 years

First QC Date

August 3, 2005

Last Update Submit

June 22, 2011

Conditions

HIV Infections

Keywords

Human Immunodeficiency Virusanti-retroviral therapynucleoside analoguereverse transcriptaselamivudineresistance mutationTreatment Experienced

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in HIV RNA levels at day 21

    day 21

  • Time-weighted average change from baseline in HIV RNA levels through 21 days

    21 days

Secondary Outcomes (3)

  • Change from baseline in HIV RNA levels at days 7, 14, 21

    days 7, 14, 21

  • Proportion of subjects with HIV RNA levels <400 or <50 at days 7, 14, 21, and weeks 24 and 48

    days 7, 14, 21, and weeks 24 and 48

  • Change from baseline and change in ratio of CD4+ and CD8+ cells at day 21 and weeks 24 and 48

    day 21 and weeks 24 and 48

Study Arms (3)

600mg BID ATC

EXPERIMENTAL

600mg BID ATC

Drug: AVX754

800mg BID ATC

EXPERIMENTAL

800mg BID ATC

Drug: AVX754

150mg BID 3TC

ACTIVE COMPARATOR

150mg BID 3TC

Drug: 3TC

Interventions

AVX754DRUG

apricitabine, 600mg BID or 800mg BID

Also known as: apricitabine
600mg BID ATC800mg BID ATC
3TCDRUG

3TC, 150mg BID

Also known as: lamivudine
150mg BID 3TC

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-1 infected
  • M184V mutation in reverse transcriptase
  • Currently taking lamivudine
  • Viral load \>2000 copies/ml

You may not qualify if:

  • Hepatitis B surface antigen positive
  • Pregnant or breastfeeding females
  • Hepatitis C RNA positive and requiring treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avexa (co-ordinating sites in Australia and Argentina)

Melbourne, Victoria, 3121, Australia

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

apricitabineLamivudine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Study Officials

  • Susan W Cox, Ph D

    Avexa

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 3, 2005

First Posted

August 5, 2005

Study Start

July 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations

AU(1)