NCT00405249

CompletedPhase 2

Safety Study of Elvucitabine in HIV-1 Subjects

Thomas Jefferson University Source

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Other study identifiers

Sponsor study identifier

ACH-443-014A

Study Type

interventional

Estimated enrollment

5

Locations

1 country

Sites

1

Timeline

Study Start

September 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2006

Actual (reported)

Study Completion

November 2006

Actual (reported)

Brief Summary

The purpose of this 28 day study is to assess the viral kinetics and safety of elvucitabine.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 5 participants
Study completion date: November 2006
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2006
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
November 2006
Actual (reported)
Study Completion
November 2006
Actual (reported)
First Submitted
November 29, 2006
Actual (reported)
First Posted
November 30, 2006
Actual (reported)

Last Updated: February 4, 2009
Status Verified: February 2009
Last Update Submitted: February 3, 2009

Conditions

HIV Infections

Keywords

HIV-1Treatment Experienced

Interventions

elvucitabineDrug

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:

HIV infected, clinically stable, adults
HIVRNA 5000 -150,000, CD4 100

Sponsors & Collaborators

Thomas Jefferson University
Otherlead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, 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

Study Officials

Kathleen Squires, MD
Thomas Jefferson University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER

Study Record Dates

First Submitted

November 29, 2006

First Posted

November 30, 2006

Study Start

September 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2006

Actual (reported)

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Phase 2Completed

Genotypically documented M184V variant

Receiving stable ART.

You may not qualify if:

Hep B
HIV-1 genotype for 4 protease inhibitors
HIV-1 genotype positive for 2 NNRTI mutations
Previous therapy with system myelosuppressive potential within 3 months of study start
Use of Epogen or Neupogen
History of cirrhosis
Alcohol or drug dependence
Inability to tolerate oral medication
Women who are pregnant or breast feeding

Contact the study team to confirm eligibility.

Immune System Diseases

Study Completion

November 2006

Actual (reported)

Last Updated

February 4, 2009

Record last verified: 2009-02

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00405249
Data provider: ClinicalTrials.gov
Source updated: 2009-02-04
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:40 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations