Open-Label, 48-Week Extension Study of Elvucitabine in Combination With Background Antiretroviral Therapy (ART) for Participants Who Have Completed Study ACH443-014A

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load.

NCT00040157

HIV Infections

TERMINATED PHASE2

UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients

NCT03164447

HIV-1 Infection

UNKNOWN PHASE2

A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past

NCT00001029

HIV Infections

COMPLETED PHASE2

A Study of Disease Progression and Anti-HIV Treatments

NCT00001068

HIV Infections

COMPLETED PHASE2

A Phase I Study of Methotrexate for HIV Infection

NCT00000834

HIV Infections

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is an open-label extension study for participants who have completed 14 days of treatment in Study ACH443-014A and meet all inclusion and exclusion criteria. Elvucitabine treatment (10 mg) will begin on Day 1 (Day 15 following completion of Study ACH443-014A) for all consenting participants in combination with background ART as determined by the Principal Investigator. Participants will have clinical and laboratory assessments every 2 weeks for the first 8 weeks and then every 4 weeks to Week 48.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Immunodeficiency Virus (HIV)-1 Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Elvucitabine

Elvucitabine 10 mg in combination with background ART

Intervention Type DRUG

Lamivudine

Intervention Type DRUG

Emtricitabine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No