HIV InfectionsPhase 4NCT00128908
Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients
A Phase 4 study testing Standard Continuous Highly Active Antiretroviral Therapy (HAART) and Rapidly Cycled HAART in people with HIV Infections, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
This is an open label, crossover pilot study to explore the safety and efficacy of a rapid cycling regimen of antiretroviral combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Standard Continuous Highly Active Antiretroviral Therapy (HAART) and Rapidly Cycled HAART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2005to Jan 2007
- 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-1 infected patients
- At least 18 years of age
- Males or non-pregnant, non-lactating females
- Documented virological treatment failure on at least 3 classes of antiretroviral drugs
- No adequate antiretroviral therapy possible with currently available antiretroviral agents
- Virological treatment failure is defined as plasma HIV-1 RNA levels > 5000 while taking at least three different antiretroviral drugs
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
HIV Outpatient Clinic, Academic Medical Center
Amsterdam, North Holland, 1105AZ
About this study
Official title: Sequential HAART in Treatment Resistant HIV-1 Infected Patients
This is an open label, crossover pilot study to explore the safety and efficacy of a rapid cycling regimen of antiretroviral combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral therapy.
Read the detailed description
Mathematical modeling has suggested that cyclic use of antiretroviral therapy can be an effective strategy in lowering viral load in HIV-1 infected patients when regular triple drug combinations have lost efficacy due to the emergence of HIV resistance mutations.
This is an open label, crossover pilot study to explore the safety and efficacy of a rapid cycling regimen of antiretroviral combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral therapy.
The objectives are to study the feasibility, safety and efficacy of sequential combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral agents and who currently have no adequate treatment options available.
This is an open-label, crossover, pilot study. Patients that fail their current regimen, and who currently have no adequate treatment options left, will be randomized to start either an alternating triple combination, or to start a continuous quadruple regimen of drugs. After 6 weeks, patients will crossover from either strategy to the other strategy for another 6 weeks. Each period is preceded by an interruption of all antiretroviral therapy for 4 weeks. In the study period when regimens are alternated, two combinations of three drugs with the least possible cross-resistance will alternate every week.
- Conditions
- HIV Infections
- Being tested
- Standard Continuous Highly Active Antiretroviral Therapy (HAART), Rapidly Cycled HAART
- Keywords
- HIV-1, HAART, sequential HAART, resistance, salvage therapy, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Continuous Highly Active Antiretroviral Therapy (HAART)Drug
Rapidly Cycled HAARTDrug
| Study group | Role | What they receive |
|---|---|---|
| Continuous triple-class therapy | Active comparator | Patients will be treated with a regimen containing antiretroviral agents from 3 different classes Receives: Drug: Standard Continuous Highly Active Antiretroviral Therapy (HAART) |
| Alternating therapy | Experimental | Patients will be assigned to weekly alternating dual-class regimen Receives: Drug: Rapidly Cycled HAART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasma HIV-1 RNA load
Measured: 12 weeks
Secondary outcomes (3)
Changes in the genotype of the dominant quasispecies
Measured: 12 weeks
Replicative fitness of the dominant quasispecies
Measured: 12 weeks
Changes in CD4+ and CD8+ cell counts
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2005 (estimated)
- Study startSep 2005
- Primary completionJan 2007
- Study completionJan 2007
Why it stopped: Did not recruit
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.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch AIDS Fund
- Investigators
- Joep MA Lange, MD PhD, Study chair, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ferdinand Wit, MD PhD, Study director, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128908
- Sponsor's protocol ID
- 05IAT0061
- Other IDs
- 2004040 - Dutch AIDS Fund
- Status last verified
- Sep 2009
- First submitted
- 8 Aug 2005
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential HAART in Treatment Resistant HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT00128908
- Acronym / sponsor ID
- 05IAT0061
- Conditions
- HIV Infections
- Keywords
- HIV-1, HAART, sequential HAART, resistance, salvage therapy, Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Did not recruit
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Dutch AIDS Fund
- Study start
- Sep 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 10 Aug 2005 (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, crossover pilot study to explore the safety and efficacy of a rapid cycling regimen of antiretroviral combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral therapy.
Detailed description
Mathematical modeling has suggested that cyclic use of antiretroviral therapy can be an effective strategy in lowering viral load in HIV-1 infected patients when regular triple drug combinations have lost efficacy due to the emergence of HIV resistance mutations.
This is an open label, crossover pilot study to explore the safety and efficacy of a rapid cycling regimen of antiretroviral combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral therapy.
The objectives are to study the feasibility, safety and efficacy of sequential combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral agents and who currently have no adequate treatment options available.
This is an open-label, crossover, pilot study. Patients that fail their current regimen, and who currently have no adequate treatment options left, will be randomized to start either an alternating triple combination, or to start a continuous quadruple regimen of drugs. After 6 weeks, patients will crossover from either strategy to the other strategy for another 6 weeks. Each period is preceded by an interruption of all antiretroviral therapy for 4 weeks. In the study period when regimens are alternated, two combinations of three drugs with the least possible cross-resistance will alternate every week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous triple-class therapy | Active comparator | Drug: Standard Continuous Highly Active Antiretroviral Therapy (HAART)Patients will be treated with a regimen containing antiretroviral agents from 3 different classes |
| Alternating therapy | Experimental | Drug: Rapidly Cycled HAARTPatients will be assigned to weekly alternating dual-class regimen |
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-1 infected patients
- At least 18 years of age
- Males or non-pregnant, non-lactating females
- Documented virological treatment failure on at least 3 classes of antiretroviral drugs
- No adequate antiretroviral therapy possible with currently available antiretroviral agents
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Standard Continuous Highly Active Antiretroviral Therapy (HAART) | Drug | Continuous triple-class therapy |
| Rapidly Cycled HAART | Drug | Alternating therapy |
Primary outcome
Changes in plasma HIV-1 RNA load
Time frame: 12 weeks
3 secondary outcomes
Changes in the genotype of the dominant quasispecies
Time frame: 12 weeks
Replicative fitness of the dominant quasispecies
Time frame: 12 weeks
Changes in CD4+ and CD8+ cell counts
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Did not recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 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.
Joep MA Lange, MD PhD study chair
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Ferdinand Wit, MD PhD study director
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 Standard Continuous Highly Active Antiretroviral Therapy (HAART) and Rapidly Cycled HAART in people with HIV Infections, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 0 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 15 Sep 2009. 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 Netherlands. 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: Did not recruit). 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?
Changes in plasma HIV-1 RNA load (time frame: 12 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 15 Sep 2009.