GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults

A Pilot, Phase II, Open-label, Single Arm Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GW640385 When Administered With Ritonavir in Combination With NRTIs for 48 Weeks in HIV-1 Infected Adults

This is a proof of concept (POC) single arm study of GW640385, a protease inhibitor, in combination with RTV and 2 or more nucleoside reverse transcriptase inhibitors (NRTI) backbone. This study has a 48 week duration and is open to both treatment naive and experienced patients who are HIV positive. There are 3 intensive pharmacokinetic (PK) visits.

Study Overview

• Status: Completed
• Conditions: HIV Infection; Infection, Human Immunodeficiency Virus I
• Intervention / Treatment: Drug: Ritonavir; Drug: GW640385

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • GSK Investigational Site
  • California
    • San Francisco, California, United States, 94115
      • GSK Investigational Site
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20009
      • GSK Investigational Site
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • GSK Investigational Site
    • Orlando, Florida, United States, 32804
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • GSK Investigational Site
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • GSK Investigational Site
  • Virginia
    • Hampton, Virginia, United States, 23666
      • GSK Investigational Site
  • Washington
    • Seattle, Washington, United States, 98104
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• HIV-1 infected subjects.
• Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception.
• Plasma HIV-1 RNA (viral load) >/=1,000 copies/mL at Screening.
• CD4+ cell count >/= 200 cells/mm3 at Screening.
• Be able to receive at least two of the following NRTIs (3TC, FTC, d4T, ddI or ZDV)to build a nucleoside backbone regimen.
• Willing and able to provide signed and dated written informed consent prior to study entry.

Exclusion criteria:

• Active CDC Class C disease.
• Pregnant or breastfeeding women.
• Protocol-specified laboratory abnormalities at Screening.
• Personal or family history of autoimmune disease.
• History or current indication of thyroid dysfunction or current thyroid gland abnormalities.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects with plasma HIV-1 RNA <400 copies/ml. Incidence of serious adverse events, rash and thyroid function abnormalities. GW640385 PK parameters.	throughout the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes over time in HIV-1 viral load and CD4+ cell counts. Incidence of adverse events and laboratory abnormalities. GW640385 and RTV PK parameters. Development of resistance in subjects with virologic failure.	throughout the study

Collaborators and Investigators

• Sponsor: ViiV Healthcare

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: November 21, 2005
• First Submitted That Met QC Criteria: November 22, 2005
• First Posted (Estimate): November 23, 2005

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 25, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: HIV-1 protease inhibitor GW640385 ritonavir RTV
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir
• Other Study ID Numbers: HPR10006