NCT00312039

Brief Summary

Human immunodeficiency virus (HIV)-1 infected participants receiving long-term therapy with lamivudine or emtricitabine (nucleoside reverse transcriptase inhibitors \[NRTIs\]) are at risk for the development of a mutation at position M184 on the HIV reverse transcriptase gene. This mutation confers resistance to both drugs (\>100 fold increase in the concentration of drug producing 50% inhibition \[IC50\]). In-vitro studies with elvucitabine have shown that HIV-1 isolates with the M184V mutation show only a 10-fold increase in IC50 as compared to wild type HIV-1. Alexion Pharmaceuticals Inc. intention is to demonstrate that 10 milligrams (mg) of elvucitabine, administered once per day for 14 days with continued background anti-HIV-1 medications, will demonstrate a fall in HIV-1 ribonucleic acid (RNA) plasma levels, as compared to baseline. The data from this study will guide dosing in future long-term studies in HIV-1 infected participants with the M184V mutation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_1 hiv-infections

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

8 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

March 31, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2007

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

1.6 years

First QC Date

April 5, 2006

Last Update Submit

August 22, 2023

Conditions

HIV Infections

Keywords

HIV-1treatment experienced

Outcome Measures

Primary Outcomes (1)

  • Reduction In Viral Load

    14 days

Secondary Outcomes (1)

  • Number of Participants with a Treatment Adverse Event

    14 days

Study Arms (2)

A

EXPERIMENTAL
Drug: Elvucitabine

B

ACTIVE COMPARATOR
Drug: Lamivudine

Interventions

ElvucitabineDRUG

Elvucitabine 10 mg QD for 14days

A
LamivudineDRUG

Lamivudine 300 mg QD for 14 days

B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically stable HIV-1 infected participants
  • Ages \>18 and \<65 years
  • Documented M184V mutation
  • CD4 cell count \>100 cells/mL
  • Plasma HIV-1 RNA levels \>5000 and \<150,000 copies/milliliter (mL)
  • Currently receiving lamivudine or emtricitabine
  • Other hematologic and metabolic parameters must be met.
  • Provide written informed consent

You may not qualify if:

  • Hepatitis B antigen positive
  • HIV-1 genotype positive for more than or equal to 4 protease mutations
  • HIV-1 genotype positive for more than or equal to 2 non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations
  • Previous therapy with cytotoxic or myelosuppressive drugs in the past 3 months
  • Evidence or history of cirrhosis
  • Women who are pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Clinical Trial Site

Birmingham, Alabama, 35294, United States

Location

Clinical Trial Site

Sacramento, California, 95817, United States

Location

Clinical Trial Site

Miami, Florida, 33136, United States

Location

Clinical Trial Site

Orlando, Florida, 32803, United States

Location

Clinical Trial Site

West Palm Beach, Florida, 33401, United States

Location

Clinical Trial Site

Atlanta, Georgia, 30308, United States

Location

Clinical Trial Site

New York, New York, 10003, United States

Location

Clinical Trial Site

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

dexelvucitabineLamivudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus 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 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2006

First Posted

April 7, 2006

Study Start

March 31, 2006

Primary Completion

October 31, 2007

Study Completion

October 31, 2007

Last Updated

August 25, 2023

Record last verified: 2023-08

Locations

US(8)