Human Immunodeficiency Virus (HIV)NCT00992654
A Treatment Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India
A study testing Open Label Treatment Access: Maraviroc in people with Human Immunodeficiency Virus (HIV), run by ViiV Healthcare.
Trial summary
The new protocol will allow the patients enrolled on A4001050 to have continuous access of Maraviroc and the treatment will not be interrupted until the drug is commercially available in India. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus (HIV)
- What is being tested?
- Open Label Treatment Access: Maraviroc
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who complete the A4001050 study and are continuing to derive benefit from Maraviroc.
- Subjects who are willing and able to comply with scheduled visits, treatment plan and other study procedures.
Who cannot join
- Subjects who discontinued in A4001050 study.
- Unable to provide consent.
About this study
Official title: A Local, Multicentre, Open Label Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India
The new protocol will allow the patients enrolled on A4001050 to have continuous access of Maraviroc and the treatment will not be interrupted until the drug is commercially available in India.
- Conditions
- Human Immunodeficiency Virus (HIV)
- Being tested
- Open Label Treatment Access: Maraviroc
- Keywords
- Open Label Access Program, Treatment experienced
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Label Treatment Access: MaravirocDrug
Also called Maraviroc, Celsentri, Selzentry
Oral dosing twice daily. The dose will depend on the optimized background therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies 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
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992654
- Sponsor's protocol ID
- A4001096
- Other IDs
- A4001050
- Status last verified
- Sep 2018
- First submitted
- 8 Oct 2009
- Last updated
- 27 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Local, Multicentre, Open Label Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India
- ClinicalTrials.gov ID
- NCT00992654
- Acronym / sponsor ID
- A4001096
- Conditions
- Human Immunodeficiency Virus (HIV)
- Keywords
- Open Label Access Program, Treatment experienced
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- First posted
- 9 Oct 2009 (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 new protocol will allow the patients enrolled on A4001050 to have continuous access of Maraviroc and the treatment will not be interrupted until the drug is commercially available in India.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who complete the A4001050 study and are continuing to derive benefit from Maraviroc.
- Subjects who are willing and able to comply with scheduled visits, treatment plan and other study procedures.
Key exclusion criteria (2 listed)
- Subjects who discontinued in A4001050 study.
- Unable to provide consent.
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 |
|---|---|---|
| Open Label Treatment Access: MaravirocAlso: Maraviroc, Celsentri, SelzentryOral dosing twice daily. The dose will depend on the optimized background therapy. | 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 27 Sep 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A study testing Open Label Treatment Access: Maraviroc in people with Human Immunodeficiency Virus (HIV), run by ViiV Healthcare.
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 2 inclusion and 2 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 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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 27 Sep 2018.