Clinical trial NCT00257621: GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infection, Human Immunodeficiency Virus I
HIV Infection
Keywords: HIV-1 protease inhibitor GW640385 ritonavir RTV
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
First posted: 2005-11-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of subjects with plasma HIV-1 RNA <400 copies/ml. Incidence of serious adverse events, rash and thyroid function abnormalities. GW640385 PK parameters.
timeFrame: throughout the study
Secondary outcomes:
measure: 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.
timeFrame: throughout the study
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Washington, D.C.
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Santa Fe
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Hampton
country: United States
facility: GSK Investigational Site
state: Virginia
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: