HIV-1NCT00334022
Fuzeon Viral Decay Pilot Study
A study testing enfuvirtide in people with HIV-1, run by Canadian Immunodeficiency Research Collaborative at 1 site in Canada.
Trial summary
In order to better understand the source(s) and the mechanism(s) of HIV persistence and to potentially lead to further suppression of HIV from viral reservoirs, we propose to examine the effect of co-administration of enfuvirtide, an entry inhibitor of HIV, on diminution of the size of the viral reservoir in infected… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV-1
- What is being tested?
- enfuvirtide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2006to Jan 2010
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient must be HIV infected
- Patient must be > 18 years old
- Patient must be taking standard combination antiretroviral therapy with 2-3 NRTIs and 1-2 PIs or a NNRTIs for at least five years
- Patient must have a viral load < 50 copies/mL (using the standard available methods of detection) during the entire time on standard combination antiretroviral therapy except for initial fall of viral load
- Patient must have a CD4 count above 400 cells/mm3 in last 3 months
- Female patient must agree to use two methods of birth control or abstinence during the period of the study
- Patient has to have signed full informed consent
Who cannot join
- Patient who would have difficulty participating in a trial due to non-adherence or substance abuse
- Patient who have taken mono or dual antiretroviral therapy
- Patient who have had a viral load > 50 copies/mL on any antiretroviral regimen
- Patient with any of the following abnormal laboratory test results in screening:
- Hemaglobin < 100 g/L
- Neutrophil count < 750 cells/uL
Show all 13Show fewer
- Platelet count < 50,000 cells/L
- AST or ALT > 5X the upper limit of normal
- Creatinine > 250 umol/L
- Patient with a malignancy
- Patient with other significant underlying disease (non-HIV) that might impinge upon disease progression or death
- Patient with an active AIDS-defining illnesses in the past six months
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Controlled Trial of Adding Enfuvirtide to Standard Combination Antiretroviral Therapy in HIV-infected Individuals With Full Virologic Suppression to Further Suppress Proviral HIV DNA
In order to better understand the source(s) and the mechanism(s) of HIV persistence and to potentially lead to further suppression of HIV from viral reservoirs, we propose to examine the effect of co-administration of enfuvirtide, an entry inhibitor of HIV, on diminution of the size of the viral reservoir in infected individuals who are receiving effective antiviral therapy for extended periods of time (> 5 years).
- Conditions
- HIV-1
- Being tested
- enfuvirtide
- Keywords
- Fuzeon, Viral Decay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enfuvirtideDrug
1ml BID
| Study group | Role | What they receive |
|---|---|---|
| Did not receive enfuvirtide | Placebo comparator | patients were randomized to either receive enfuviratide or not receive it Receives: Drug: enfuvirtide |
| enfuvirtide | Active comparator | enfuvirtide 1ml BID Receives: Drug: enfuvirtide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.
The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.
Measured: 6 months
Secondary outcomes (8)
To determine the change of proviral HIV-1 DNA from baseline to month 3
To determine the change of proviral HIV-1 DNA from baseline to month 3
Measured: 3 months
To determine the change of proviral HIV-1 DNA from months 6 to 9 after the enfurvitide has been stopped for 3 months in the treatment arm
To determine the change of proviral HIV-1 DNA from months 6 to 9 after the enfurvitide has been stopped for 3 months in the treatment arm
Measured: 9 months
To quantify plasma HIV (limit of detection 2 copies/ml of plasma)
To quantify plasma HIV (limit of detection 2 copies/ml of plasma)
Measured: 9 months
To quantify cell associated HIV RNA (unspliced and multiply spliced) in resting and activated CD4+ T cells
To quantify cell associated HIV RNA (unspliced and multiply spliced) in resting and activated CD4+ T cells
Measured: 9 months
To determine the decay characteristics of HIV in resting CD4+ T cells by quantitative co-culture assays
To determine the decay characteristics of HIV in resting CD4+ T cells by quantitative co-culture assays
Measured: 9 months
To determine the half-life of HIV in resting CD4+ T cells
To determine the half-life of HIV in resting CD4+ T cells
Measured: 9months
To carry out phylogenetic analysis of HIV in the plasma, resting, and activated CD4+ T cell compartments
To carry out phylogenetic analysis of HIV in the plasma, resting, and activated CD4+ T cell
Measured: 9 months
To quantify the amount of HIV in gastrointestinal-associated lymphoid tissue (GALT) by quantitative co-culture assays (as part of a sub-study - see GALT sub-study)
To quantify the amount of HIV in gastrointestinal-associated lymphoid tissue (GALT) by quantitative co-culture assays (as part of a sub-study - see GALT sub-study)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2006 (estimated)
- Study startFeb 2006
- Primary completionJul 2007
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Immunodeficiency Research Collaborative
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Colin Kovacs, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334022
- Sponsor's protocol ID
- Roche-FVD-1
- Status last verified
- Jun 2012
- First submitted
- 2 Jun 2006
- Last updated
- 5 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of Adding Enfuvirtide to Standard Combination Antiretroviral Therapy in HIV-infected Individuals With Full Virologic Suppression to Further Suppress Proviral HIV DNA
- ClinicalTrials.gov ID
- NCT00334022
- Acronym / sponsor ID
- Roche-FVD-1
- Conditions
- HIV-1
- Keywords
- Fuzeon, Viral Decay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Canadian Immunodeficiency Research CollaborativeUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Feb 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 6 Jun 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.
In order to better understand the source(s) and the mechanism(s) of HIV persistence and to potentially lead to further suppression of HIV from viral reservoirs, we propose to examine the effect of co-administration of enfuvirtide, an entry inhibitor of HIV, on diminution of the size of the viral reservoir in infected individuals who are receiving effective antiviral therapy for extended periods of time (> 5 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Did not receive enfuvirtide | Placebo comparator | Drug: enfuvirtidepatients were randomized to either receive enfuviratide or not receive it |
| enfuvirtide | Active comparator | Drug: enfuvirtideenfuvirtide 1ml BID |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patient must be HIV infected
- Patient must be > 18 years old
- Patient must be taking standard combination antiretroviral therapy with 2-3 NRTIs and 1-2 PIs or a NNRTIs for at least five years
- Patient must have a viral load < 50 copies/mL (using the standard available methods of detection) during the entire time on standard combination antiretroviral therapy except for initial fall of viral load
- Patient must have a CD4 count above 400 cells/mm3 in last 3 months
Key exclusion criteria (13 listed)
- Patient who would have difficulty participating in a trial due to non-adherence or substance abuse
- Patient who have taken mono or dual antiretroviral therapy
- Patient who have had a viral load > 50 copies/mL on any antiretroviral regimen
- Patient with any of the following abnormal laboratory test results in screening:
- Patient with a malignancy
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 |
|---|---|---|
| enfuvirtide1ml BID | Drug | Did not receive enfuvirtide, enfuvirtide |
Primary outcome
The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.
Time frame: 6 months
The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.
8 secondary outcomes
To determine the change of proviral HIV-1 DNA from baseline to month 3
Time frame: 3 months
To determine the change of proviral HIV-1 DNA from months 6 to 9 after the enfurvitide has been stopped for 3 months in the treatment arm
Time frame: 9 months
To quantify plasma HIV (limit of detection 2 copies/ml of plasma)
Time frame: 9 months
To quantify cell associated HIV RNA (unspliced and multiply spliced) in resting and activated CD4+ T cells
Time frame: 9 months
To determine the decay characteristics of HIV in resting CD4+ T cells by quantitative co-culture assays
Time frame: 9 months
To determine the half-life of HIV in resting CD4+ T cells
Time frame: 9months
To carry out phylogenetic analysis of HIV in the plasma, resting, and activated CD4+ T cell compartments
Time frame: 9 months
To quantify the amount of HIV in gastrointestinal-associated lymphoid tissue (GALT) by quantitative co-culture assays (as part of a sub-study - see GALT sub-study)
Time frame: 9 months
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 5 Jun 2012.
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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.
Colin Kovacs, MD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enfuvirtide in people with HIV-1, run by Canadian Immunodeficiency Research Collaborative at 1 site in Canada.
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 7 inclusion and 13 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 5 Jun 2012. 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 Canada. 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. Some participants in this study may receive a placebo. 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 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?
The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6. (time frame: 6 months). 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 5 Jun 2012.