A Multiple Ascending Dose Study of BMS-707035 in HIV-1 Infected Subjects

This study has been terminated.

First Received: November 8, 2006 Last Updated: August 22, 2007 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00397566

Purpose

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

Condition	Intervention	Phase
HIV Infections	Drug: HIV Integrase Inhibitor (BMS-707035)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
Official Title:	Randomized, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-707035 in HIV-1 Infected Subjects

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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
Assess plasma protein binding and intracellular concentration in PBMC for BMS-707035

Estimated Enrollment:	50
Study Start Date:	January 2008

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	AI441-008
Study First Received:	November 8, 2006
Last Updated:	August 22, 2007
ClinicalTrials.gov Identifier:	NCT00397566 History of Changes
Health Authority:	United States: Food and Drug Administration; South Africa: Medicines Control Council; Mexico: Secretaría de Salud de México (Mexico's Ministry of Health)

Keywords provided by Bristol-Myers Squibb:

HIV
Treatment Experienced

Study placed in the following topic categories:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
HIV Integrase Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes

Virus Diseases
Anti-Retroviral Agents
HIV Infections
Integrase Inhibitors
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
HIV Integrase Inhibitors

Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Anti-Retroviral Agents
Integrase Inhibitors
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on September 01, 2009