HIV InfectionsPhase 4PALMNCT00981318
Pilot Assessment of Lopinavir/Ritonavir and Maraviroc
A Phase 4 study testing lopinavir/ritonavir plus maraviroc in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by Rodwick, Barry M., M.D. at 1 site in United States.
Trial summary
This is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no nucleoside medications) in HIV patients failing their initial antiviral therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Acquired Immunodeficiency Syndrome
- What is being tested?
- lopinavir/ritonavir plus maraviroc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to May 2015
- Phase
- Phase 4
- 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 viral load > 1,000 on current antiviral medications
- No resistance to study medications
- Over 18 years of age
Who cannot join
- Hepatitis B co-infection
- Pregnancy
- Previous therapy with either of the study medications
- Ongoing substance abuse
- Significant history of other physical disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Barry M. Rodwick, M. D.
Safety Harbor, Florida, 34695
About this study
Official title: Pilot Assessment of Lopinavir/Ritonavir and Maraviroc in Experienced Patients
This is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no nucleoside medications) in HIV patients failing their initial antiviral therapy.
Read the detailed description
As long-term toxicity to many of the nucleoside medications have become known, interest has increased in treatment regimens that do not use these medications. This study is to assess the response of one such "nucleoside-sparing" therapy in patients who are showing failure to their initial nucleoside-containing treatment regimen.
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome
- Being tested
- lopinavir/ritonavir plus maraviroc
- Keywords
- Acquired Immunodeficiency Syndrome, HIV, AIDS, treatment experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lopinavir/ritonavir plus maravirocDrug
Also called Kaletra, lopinavir, Selzentry
lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid
| Study group | Role | What they receive |
|---|---|---|
| lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid | Other | single arm Receives: Drug: lopinavir/ritonavir plus maraviroc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic response defined as viral load reduction of >/= 1 log
Measured: 48 weeks
Secondary outcomes (6)
Assess proportion of patients with HIV-1 viral load < 48 copies
Measured: 48 weks
Assess time to loss of virologic response
Measured: 48 weeks
Assess development of resistance mutations in patients who develop rebound
Measured: 48 weeks
Compare serum lipid profile changes
Measured: 48 weeks
Assess safety and tolerability
Measured: 48 weeks
Assess degree of immune reconstitution
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: unable to enroll expected number of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rodwick, Barry M., M.D.
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Barry M. Rodwick, M. D., Rodwick, Barry M., M.D.
- Investigators
- Barry M. Rodwick, M. D., Principal investigator, Barry M. Rodwick, M. D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981318
- Sponsor's protocol ID
- Rodwick01
- Acronym
- PALM
- Status last verified
- Jun 2015
- First submitted
- 19 Sep 2009
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Assessment of Lopinavir/Ritonavir and Maraviroc in Experienced Patients
- ClinicalTrials.gov ID
- NCT00981318
- Acronym / sponsor ID
- PALM / Rodwick01
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome
- Keywords
- Acquired Immunodeficiency Syndrome, HIV, AIDS, treatment experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to enroll expected number of subjects
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Rodwick, Barry M., M.D.
- Collaborators
- Abbott
- Study start
- Dec 2009
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 22 Sep 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.
This is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no nucleoside medications) in HIV patients failing their initial antiviral therapy.
Detailed description
As long-term toxicity to many of the nucleoside medications have become known, interest has increased in treatment regimens that do not use these medications. This study is to assess the response of one such "nucleoside-sparing" therapy in patients who are showing failure to their initial nucleoside-containing treatment regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid | Other | Drug: lopinavir/ritonavir plus maravirocsingle arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV viral load > 1,000 on current antiviral medications
- No resistance to study medications
- Over 18 years of age
Key exclusion criteria (5 listed)
- Hepatitis B co-infection
- Pregnancy
- Previous therapy with either of the study medications
- Ongoing substance abuse
- Significant history of other physical disease
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 |
|---|---|---|
| lopinavir/ritonavir plus maravirocAlso: Kaletra, lopinavir, Selzentrylopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid | Drug | lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid |
Primary outcome
Virologic response defined as viral load reduction of >/= 1 log
Time frame: 48 weeks
6 secondary outcomes
Assess proportion of patients with HIV-1 viral load < 48 copies
Time frame: 48 weks
Assess time to loss of virologic response
Time frame: 48 weeks
Assess development of resistance mutations in patients who develop rebound
Time frame: 48 weeks
Compare serum lipid profile changes
Time frame: 48 weeks
Assess safety and tolerability
Time frame: 48 weeks
Assess degree of immune reconstitution
Time frame: 48 weeks
Results and safety
The study was stopped early (reason given: unable to enroll expected number of subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
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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.
Barry M. Rodwick, M. D. principal investigator
Barry M. Rodwick, M. D.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lopinavir/ritonavir plus maraviroc in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by Rodwick, Barry M., M.D. at 1 site 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 3 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 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: unable to enroll expected number of subjects). 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.
What does the primary outcome measure?
Virologic response defined as viral load reduction of >/= 1 log (time frame: 48 weeks). 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 23 Jun 2015.