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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infection, Human Immunodeficiency Virus I HIV Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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GW640385

Intervention Type DRUG

Ritonavir

Intervention Type DRUG

Other Intervention Names

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GW640385

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No