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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00257621

Enrollment

Registered

2005-11-23

Start date

2004-10-31

Completion date

2007-01-31

Last updated

2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection, Infection, Human Immunodeficiency Virus I

Keywords

HIV-1 protease inhibitor GW640385 ritonavir RTV

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.

Interventions

DRUGGW640385

DRUGRitonavir

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026