HIV InfectionNCT00321438
Observational Study of HIV-Infected Subjects With X4-Tropic or Non-Phenotypeable Virus
An observational study of HIV Infection, run by GlaxoSmithKline at 15 sites in United States.
Trial summary
The purpose of this study is to measure viral tropism over time in subjects with X4-tropic or non-phenotypeable virus while receiving standard of care therapy. This is an observational study. No investigational treatment will be administered through this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- How many people
- 150 participants
- Where
- 15 sitesUnited States
- Study dates
- Jul 2005to not given
- Phase
- Observational
- 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-infected.
- Screening viral load at least 5000copies/mL.
- X4-tropic only or non-phenotypeable virus at screening.
- Total prior antiretroviral experience of at least 3 months and documented resistance to at least one drug in each of the following classes: NRTI, NNRTI, and PI, stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks before screening.
- Able to receive a ritonavir-boosted protease inhibitor during treatment studies.
- Women of childbearing potential must use specific forms of contraception.
Who cannot join
- R5-tropic only or R5/X4-tropic virus at screening, changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of observational study.
- Pregnant or breastfeeding women.
- Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, cancer, or severe illness.
- Current use of certain medications may exclude participation in this study.
- Additional qualifying criteria and laboratory test requirements to be determined by study physician.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
GSK Investigational Site
Atlanta, Georgia, 30308/30309
GSK Investigational Site
Atlanta, Georgia, 30339
GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Charlotte, North Carolina, 28209
GSK Investigational Site
Decatur, Georgia, 30033
GSK Investigational Site
East Orange, New Jersey, 07018
GSK Investigational Site
Fort Myers, Florida, 33901
GSK Investigational Site
Hampton, Virginia, 23666
GSK Investigational Site
Key West, Florida, 33040
GSK Investigational Site
Los Angeles, California, 90069
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
New York, New York, 10014
GSK Investigational Site
Plantation, Florida, 33317
GSK Investigational Site
Tarzana, California, 91356
GSK Investigational Site
Washington D.C., District of Columbia, 20037
About this study
Official title: Prospective, Observational Study of Subjects With CXCR4-Tropic or Non-Phenotypeable HIV to Assess Changes in Tropism Over Time
The purpose of this study is to measure viral tropism over time in subjects with X4-tropic or non-phenotypeable virus while receiving standard of care therapy. This is an observational study. No investigational treatment will be administered through this study.
- Conditions
- HIV Infection
- Keywords
- HIV-1, GW873140, CCR5 antagonist, experienced, treatment experienced
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321438
- Sponsor's protocol ID
- CCR104629
- Status last verified
- May 2009
- First submitted
- 1 May 2006
- Last updated
- 18 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Study of Subjects With CXCR4-Tropic or Non-Phenotypeable HIV to Assess Changes in Tropism Over Time
- ClinicalTrials.gov ID
- NCT00321438
- Acronym / sponsor ID
- CCR104629
- Conditions
- HIV Infection
- Keywords
- HIV-1, GW873140, CCR5 antagonist, experienced, treatment experienced
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 150 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- First posted
- 3 May 2006 (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.
The purpose of this study is to measure viral tropism over time in subjects with X4-tropic or non-phenotypeable virus while receiving standard of care therapy. This is an observational study. No investigational treatment will be administered through this study.
Study design
- Time perspective
- Prospective
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-infected.
- Screening viral load at least 5000copies/mL.
- X4-tropic only or non-phenotypeable virus at screening.
- Total prior antiretroviral experience of at least 3 months and documented resistance to at least one drug in each of the following classes: NRTI, NNRTI, and PI, stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks before screening.
- Able to receive a ritonavir-boosted protease inhibitor during treatment studies.
Key exclusion criteria (5 listed)
- R5-tropic only or R5/X4-tropic virus at screening, changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of observational study.
- Pregnant or breastfeeding women.
- Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, cancer, or severe illness.
- Current use of certain medications may exclude participation in this study.
- Additional qualifying criteria and laboratory test requirements to be determined by study physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2009.
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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
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by GlaxoSmithKline at 15 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: stopped early, as of the sponsor's last update on 18 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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.
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 18 May 2009.