Trials Sponsors Conditions Drugs Pricing

Conditions

HIV Infections

Keywords

Extension studyHIV-1 infectionTreatment naive

Outcome Measures

Primary Outcomes (1)

Determine Safety Profile Of Elvucitabine Measured By Incidence Of Study Discontinuations And Incidence, Severity, And Type Of Adverse Events And Clinically Significant Changes Or Abnormalities In Participant's Clinical Laboratory Results.
48 months

Secondary Outcomes (1)

Determination Of The Continued Efficacy Of Elvucitabine As Measured By The Change In Helper T Cell (CD4) Count.
48 months

Study Arms (1)

Elvucitabine

EXPERIMENTAL

Participants currently receiving elvucitabine will continue elvucitabine as part of their antiretroviral therapy (ART) regimen for an additional 48 months.

Drug: Elvucitabine

Interventions

ElvucitabineDrug

10 milligrams (mg) elvucitabine daily as part of an ART regimen

Elvucitabine

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Participants must have successfully completed 96 weeks of elvucitabine therapy in Protocol ACH443-015 or participants have completed 48 weeks of elvucitabine therapy in Protocol ACH443-014A-018 .

You may not qualify if:

Sponsors & Collaborators

Achillion, a wholly owned subsidiary of Alexion
Industrycollaborator
Alexion Pharmaceuticals, Inc.
Industrylead

Study Sites (5)

Clinical Trial Site

Orlando, Florida, 32803, United States

Clinical Trial Site

Pensacola, Florida, 32504, United States

Clinical Trial Site

Newark, New Jersey, 07102, United States

Clinical Trial Site

Austin, Texas, 78705, United States

Clinical Trial Site

Dallas, Texas, 75204, United States

MeSH Terms

Conditions

HIV Infections

Interventions

dexelvucitabine

Condition Hierarchy (Ancestors)

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

Enrollment

7 participants (actual enrollment reported by the registry).

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

May 8, 2008

First Posted

May 12, 2008

Study Start

May 2008

Date type not reported

This date has not been verified as actual or estimated.

An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Elvucitabine

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Elvucitabine

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations