Infection, Human Immunodeficiency VirusNCT01776996
An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc
A study testing Continued Access Arm in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 28 sites in 7 countries.
Trial summary
This is an open-label protocol designed to provide continued access to maraviroc to only those subjects who have completed previous studies of maraviroc and continue to receive clinical benefit. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- What is being tested?
- Continued Access Arm
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 28 sitesin 7 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Subject has participated in a clinical trial that evaluated maraviroc and is continuing to derive clinical benefit from maraviroc treatment.
- Subject must agree to use an acceptable method of contraception for the duration of the study as outlined at the end of the inclusion criteria.
- Subject agrees to the specified study procedures.
Who cannot join
- Subject who is an investigational site staff member or an employee of the Sponsor that is directly involved in the conduct of the trial.
- Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Contra-indications to use of maraviroc as described in the Investigator Brochure.
- Past documented dual/mixed or C-X-C chemokine receptor type 4 HIV tropism.
Trial locations and contacts
28 sites in 7 countries.
28 sites in 7 countries
South Africa9 sites
GSK Investigational Site
Bloemfontein, 9301
GSK Investigational Site
Dundee, 3000
GSK Investigational Site
Gauteng, Gauteng, 2047
GSK Investigational Site
Port Elizabeth, Eastern Cape, 6001
GSK Investigational Site
Port Elizabeth, 6070
GSK Investigational Site
Pretoria, 0083
GSK Investigational Site
Pretoria North, 0116
GSK Investigational Site
Soweto, Gauteng, 2013
GSK Investigational Site
Westdene, 2092
Russia6 sites
GSK Investigational Site
Moscow, 105275
GSK Investigational Site
Moscow, 129110
GSK Investigational Site
N.Novgorod, 603005
GSK Investigational Site
Saint Petersburg, 190103
GSK Investigational Site
Saint Petersburg, 196645
GSK Investigational Site
Smolensk, 214006
Argentina4 sites
GSK Investigational Site
Buenos Aires, Buenos Aires, 1202
GSK Investigational Site
Buenos Aires, C1264AAV
GSK Investigational Site
Buenos Aires, C1282AEN
GSK Investigational Site
Rosario, Santa Fe Province, 2000
Belgium3 sites
GSK Investigational Site
Brussels, 1000
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Leuven, 3000
Switzerland3 sites
GSK Investigational Site
Bern, CH-3010
GSK Investigational Site
Lugano, 6900
GSK Investigational Site
Zurich, 8091
Italy2 sites
GSK Investigational Site
Milan, Lombardy, 20127
GSK Investigational Site
Modena, 41124
About this study
This is an open-label protocol designed to provide continued access to maraviroc to only those subjects who have completed previous studies of maraviroc and continue to receive clinical benefit.
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- Continued Access Arm
- Keywords
- Expanded access, HIV, maraviroc
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continued Access ArmDrug
All subjects will be on maraviroc 300 mg twice a day, unless a dose adjustment is required due to certain concomitant medications. For those subjects in South Africa and Argentina who were previously receiving Combivir along with maraviroc in Study A4001026, Combivir will be supplied as tablets containing 150 mg lamivudine and 300 mg zidovudine. One Combivir tablet will be taken orally twice a day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency VirusStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776996
- Sponsor's protocol ID
- 116278
- Status last verified
- Apr 2017
- First submitted
- 24 Jan 2013
- Last updated
- 6 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc
- ClinicalTrials.gov ID
- NCT01776996
- Acronym / sponsor ID
- 116278
- Conditions
- Infection, Human Immunodeficiency Virus
- Keywords
- Expanded access, HIV, maraviroc
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- First posted
- 28 Jan 2013 (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 an open-label protocol designed to provide continued access to maraviroc to only those subjects who have completed previous studies of maraviroc and continue to receive clinical benefit.
Study design
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Subject has participated in a clinical trial that evaluated maraviroc and is continuing to derive clinical benefit from maraviroc treatment.
- Subject must agree to use an acceptable method of contraception for the duration of the study as outlined at the end of the inclusion criteria.
- Subject agrees to the specified study procedures.
Key exclusion criteria (4 listed)
- Subject who is an investigational site staff member or an employee of the Sponsor that is directly involved in the conduct of the trial.
- Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Contra-indications to use of maraviroc as described in the Investigator Brochure.
- Past documented dual/mixed or C-X-C chemokine receptor type 4 HIV tropism.
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 |
|---|---|---|
| Continued Access ArmAll subjects will be on maraviroc 300 mg twice a day, unless a dose adjustment is required due to certain concomitant medications. For those subjects in South Africa and Argentina who were previously receiving Combivir along with maraviroc in Study A4001026, Combivir will be supplied as tablets containing 150 mg lamivudine and 300 mg zidovudine. One Combivir tablet will be taken orally twice a day. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 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 study director
ViiV Healthcare
28 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continued Access Arm in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 28 sites in 7 countries.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in South Africa, Russia, Argentina, Belgium, Switzerland and 2 more countries. 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?
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 6 Apr 2017.