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OpenTrials
Completed

NCT Number: NCT00380159

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

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.

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Key information

Conditions

Human Immunodeficiency Virus (HIV)-1 Infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Trial Site, Santo Domingo, Dominican Republic

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • Failure to meet inclusion criteria

Treatment and study plan

Elvucitabine

Drug

Elvucitabine 10 mg in combination with background ART

Lamivudine

Drug

Emtricitabine

Drug

Primary outcomes

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

    Time frame: 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

    Time frame: September 2008

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Collaborators

  • Achillion, a wholly owned subsidiary of Alexion

Registry information

Official study title

An Open-Label, 48-Week Extension Study of Elvucitabine Administered In Combination With Background Antiretroviral Agents in Participants Who Have Completed 14 Days of Treatment in Protocol ACH443-014A.

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Sep 25, 2006
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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