NCT00257621

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

9 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

October 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

November 21, 2005

Last Update Submit

May 25, 2017

Conditions

Infection, Human Immunodeficiency Virus IHIV Infection

Keywords

HIV-1 protease inhibitor GW640385 ritonavir RTV

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

GW640385DRUG
RitonavirDRUG
Also known as: GW640385

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

GSK Investigational Site

Phoenix, Arizona, 85006, United States

Location

GSK Investigational Site

San Francisco, California, 94115, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20009, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

GSK Investigational Site

Orlando, Florida, 32804, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30308, United States

Location

GSK Investigational Site

Santa Fe, New Mexico, 87505, United States

Location

GSK Investigational Site

Hampton, Virginia, 23666, United States

Location

GSK Investigational Site

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

InfectionsHIV Infections

Interventions

Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2005

First Posted

November 23, 2005

Study Start

October 1, 2004

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(9)