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

ViiV Healthcare

Status and phase

Completed

Phase 2

Conditions

HIV Infection

Infection, Human Immunodeficiency Virus I

Treatments

Drug: GW640385

Drug: Ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00257621

HPR10006

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.