Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00257621

Public ClinicalTrials.gov record NCT00257621. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 10:10 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00257621
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
ViiV Healthcare
Industry
Enrollment
30 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2004
Primary completion
Dec 31, 2006
Completion
Dec 31, 2006
Last update posted
May 29, 2017

2004 – 2007

United States locations

U.S. sites
9
U.S. states
8
U.S. cities
9
Facility City State ZIP Site status
GSK Investigational Site Phoenix Arizona 85006
GSK Investigational Site San Francisco California 94115
GSK Investigational Site Washington D.C. District of Columbia 20009
GSK Investigational Site Fort Lauderdale Florida 33308
GSK Investigational Site Orlando Florida 32804
GSK Investigational Site Atlanta Georgia 30308
GSK Investigational Site Santa Fe New Mexico 87505
GSK Investigational Site Hampton Virginia 23666
GSK Investigational Site Seattle Washington 98104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00257621, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 29, 2017 · Synced Sep 2, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00257621 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →