NCT00380159

Brief Summary

To assess the safety of 48 weeks of treatment with 10 milligrams (mg) of elvucitabine in combination with background antiretroviral therapy (ART) in participants who completed Study ACH443-014A and meet the inclusion and exclusion criteria.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2006

Geographic Reach
4 countries

7 active sites

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

September 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

2.3 years

First QC Date

September 21, 2006

Last Update Submit

August 7, 2023

Conditions

Human Immunodeficiency Virus (HIV)-1 Infection

Keywords

Extension study to Study ACH443-014A

Outcome Measures

Primary Outcomes (1)

  • To Assess The Safety Of 48 Weeks Of 10 mg/daily (QD) Of Elvucitabine In Combination With ART

    September 2008

Secondary Outcomes (1)

  • To Describe The Anti-viral Activity Of Elvucitabine In Combination With ART As Measured By Plasma HIV-1 Ribonucleic Acid (RNA) Over 24 Weeks

    September 2008

Interventions

ElvucitabineDRUG

Elvucitabine 10 mg in combination with background ART

LamivudineDRUG
EmtricitabineDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants who have completed 14 days of treatment in Study ACH443-014A and who, in the Investigator's judgment, remain candidates to receive elvucitabine together with background ART.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Clinical Trial Site

Atlanta, Georgia, 30308, United States

Location

Clinical Trial Site

Cincinnati, Ohio, 45242, United States

Location

Clinical Trial Site

Santo Domingo, Dominican Republic

Location

Clinical Trial Site

Berlin, Germany

Location

Clinical Trial Site

Bonn, Germany

Location

Clinical Trial Site

Cologne, Germany

Location

Clinical Trial Site

Madrid, Spain

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

dexelvucitabineLamivudineEmtricitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2006

First Posted

September 25, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

DE(3)ES(1)US(2)DO(1)