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

ViiV Healthcare30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infection, Human Immunodeficiency Virus I HIV Infection

Interventions

GW640385DRUG

RitonavirDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

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

GSK Investigational Site

Outcomes

Primary Outcomes

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

Time frame: throughout the study

Secondary Outcomes

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.

Time frame: throughout the study

Data from ClinicalTrials.gov

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