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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257621
• Other study ID #: HPR10006
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2005
• Last updated: May 25, 2017
• Start date: October 2004
• Est. completion date: January 2007

Study information

• Verified date: May 2017
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infection
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection
• Infection, Human Immunodeficiency Virus I

Intervention

Drug:
• GW640385

• Ritonavir

Locations

Country	Name	City	State
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Hampton	Virginia
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Santa Fe	New Mexico
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
ViiV Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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