NCT00397566

Brief Summary

The purpose of this clinical research study is to assess the safety, pharmacokinetics and pharmacodynamics of BMS-707035 in subjects infected with HIV-1

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2007

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

First QC Date

November 8, 2006

Last Update Submit

April 26, 2012

Conditions

HIV Infections

Keywords

HIVTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • To assess the antiviral activity of selected doses of BMS-707035 administered orally to HIV-1 infected subjects for 10 days.

Secondary Outcomes (6)

  • Safety and tolerability with 10 days of dosing

  • Effect on QTc intervals

  • Effect on CD4+, CD8+, and CD8+CD38+ lymphocyte

  • Pharmacokinetics of multiple doses of BMS-707035 in HIV-1 infected subjects

  • Assess relationship of EC90 and exposures of BMS-707035 to the magnitude of change in viral loads

  • +1 more secondary outcomes

Interventions

HIV Integrase Inhibitor (BMS-707035)DRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HIV-1-infected subjects with CD4+ lymphocyte count ≥ 200 cells/mm3 and with plasma HIV-1 RNA ≥ 5000 copies/mL who have not been on antiretroviral (ARV) therapy for ≥ 8 weeks or who are naive to ARV, and who are otherwise medically stable as determined by medical history, physical examination, 12 lead electrocardiogram, and clinical laboratory evaluations will be eligible to participate in the study. In addition, subjects must have had no prior exposure to the Integrase Inhibitor class of compounds.
  • Female subjects must not be nursing, pregnant, or of childbearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV Infections

Interventions

Integrase InhibitorsBMS-707035

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)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses
0

Study Design

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

Study Record Dates

First Submitted

November 8, 2006

First Posted

November 9, 2006

Study Start

February 1, 2007

Study Completion

February 1, 2007

Last Updated

April 27, 2012

Record last verified: 2012-04