Skip to main content
OpenTrials
Completed

NCT Number: NCT00257621

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infection, Human Immunodeficiency Virus I Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infection HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GW640385

Drug

Ritonavir

Drug

Other names: GW640385

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Nov 23, 2005
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.