Infection, Human Immunodeficiency Virus IPhase 2NCT00257621
GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults
A Phase 2 study testing GW640385 and Ritonavir in people with Infection, Human Immunodeficiency Virus I and HIV Infection, run by ViiV Healthcare at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Human Immunodeficiency Virus I, HIV Infection
- What is being tested?
- GW640385 and Ritonavir
- How many people
- 30 participants
- Where
- 9 sitesUnited States
- Study dates
- Oct 2004to Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
GSK Investigational Site
Atlanta, Georgia, 30308
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Hampton, Virginia, 23666
GSK Investigational Site
Orlando, Florida, 32804
GSK Investigational Site
Phoenix, Arizona, 85006
GSK Investigational Site
San Francisco, California, 94115
GSK Investigational Site
Santa Fe, New Mexico, 87505
GSK Investigational Site
Seattle, Washington, 98104
GSK Investigational Site
Washington D.C., District of Columbia, 20009
About this study
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
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.
- Being tested
- GW640385, Ritonavir
- Keywords
- HIV-1 protease inhibitor GW640385 ritonavir RTV
- Medical subject headings
- Infections, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW640385Drug
RitonavirDrug
Also called GW640385
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with plasma HIV-1 RNA <400 copies/ml. Incidence of serious adverse events, rash and thyroid function abnormalities. GW640385 PK parameters.
Measured: 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.
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2005 (estimated)
- Study startOct 2004
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency Virus IStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257621
- Sponsor's protocol ID
- HPR10006
- Status last verified
- May 2017
- First submitted
- 21 Nov 2005
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00257621
- Acronym / sponsor ID
- HPR10006
- Keywords
- HIV-1 protease inhibitor GW640385 ritonavir RTV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 23 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW640385 | Drug | – |
| RitonavirAlso: GW640385 | Drug | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials, MD study director
GlaxoSmithKline
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW640385 and Ritonavir in people with Infection, Human Immunodeficiency Virus I and HIV Infection, run by ViiV Healthcare at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.