HIV InfectionsPhase 4DVDNCT00543101
Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors
A Phase 4 study testing Darunavir (DRV/r) and continue on current dual boosted PI in people with HIV Infections, run by Community Research Initiative of New England at 5 sites in United States.
Trial summary
This study will evaluate patients who have achieved virologic suppression (< 400 copies/mL) on any dual protease inhibitor (PI) combination, to determine whether patients can substitute both PIs with the single boosted PI darunavir given 600/100 ritonavir (RTV) twice daily (BID) and maintain comparable virologic… 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?
- Darunavir (DRV/r) and continue on current dual boosted PI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2007to Feb 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 years or older
- Treatment with a stable antiretroviral regimen containing two protease inhibitors, one additional FDA-licensed agent from another class (except NNRTIs) and a boosting dosage of ritonavir (100 BID or QD) for at least 12 weeks prior to screening
- No plans to make any changes in HIV treatment regimen (other than those required by study) in the next 48 weeks.
- HIV-1 RNA < 400 copies/ml based on the most recent value done as part of routine care at least 12 weeks prior to screening; and < 400 at screening
- Any CD4 count is allowed
- Written informed consent to participate
Who cannot join
- Current regimen includes an NNRTI
- CDC Class C Illness diagnosed within 30 days of screening
- Lab abnormalities as defined by a standardized grading scheme based on the DAIDS table
- Any grade 3 or 4 toxicity with the following exceptions:
- Pre-existing diabetes with glucose elevations ≥ grade 3
- triglyceride or total cholesterol elevations ≥ grade 3
Show all 18Show fewer
- Clinical or laboratory evidence of clinically significant liver impairment/dysfunction, disease or cirrhosis Note: Individuals co-infected with chronic hepatitis B or C will be allowed to enter the trial if their condition is clinically stable. Individuals diagnosed with acute viral hepatitis at screening will not be allowed to enroll during acute phase.
- Active substance abuse or significant psychiatric illness that in the opinion of the investigator might interfere with study compliance.
- Use of any investigational agents 30 days prior to screening
- Life expectancy < 6 months in the opinion of the investigator
- Prior use of darunavir or known allergy to any of the components of darunavir
- Breast feeding
- Female subject of childbearing potential not using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity.
- Note: Hormonal based contraception may not be reliable when taking darunavir, therefore to be eligible for this study, women of childbearing potential who may have vaginal intercourse should either:
- Use a double barrier method to prevent pregnancy (i.e., using a condom with either a diaphragm or cervical cap) Or
- Use hormonal based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm, cervical cap or female condom) Or
- Use an intra uterine device (IUD) in combination with a barrier contraceptive (i.e., male condom, diaphragm, cervical cap or female condom) Or
- Be non-heterosexually active, practice sexual abstinence or have a vasectomized partner (confirmed sterile).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Albany Medical Center
Albany, New York, 12208
Community Research Initiative of New England
Boston, Massachusetts, 02215
AIDS Healthcare Foundation
Los Angeles, California, 02319
Orlando Immunology Center
Orlando, Florida
Spectrum Medical Group
Phoenix, Arizona, 85012
About this study
Official title: A Randomized, Controlled Trial to Evaluate the Efficacy of Substituting Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors in Individuals With Virologic Suppression for at Least 12 Weeks
This study will evaluate patients who have achieved virologic suppression (< 400 copies/mL) on any dual protease inhibitor (PI) combination, to determine whether patients can substitute both PIs with the single boosted PI darunavir given 600/100 ritonavir (RTV) twice daily (BID) and maintain comparable virologic suppression (% < 50 c/mL) for 24 weeks.
Read the detailed description
The purpose of this study is to determine if patients who have achieved virologic suppression (< 400 copies/mL) on any dual PI combination, can substitute both PIs with the single boosted PI darunavir given 600/100 rtv bid and maintain comparable virologic suppression (% < 50 c/mL) for 24 weeks. Randomized, non-blinded, multicenter, 48 week, controlled trial to assess the non-inferiority of substituting DRV/r for a dual boosted PI combination in patients with stable virologic suppression on a regimen containing a dual boosted PI combination plus at least one additional FDA-licensed antiretroviral agent from another class. Participants will be randomized (1:1) to one of the included treatment arms.
- Conditions
- HIV Infections
- Being tested
- Darunavir (DRV/r), continue on current dual boosted PI
- Keywords
- HIV/AIDS, darunavir, Protease inhibitors, Dual boosted, 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.
Darunavir (DRV/r)Drug
Switch to DRV/r at a dose of 600/100 BID for 48 weeks
continue on current dual boosted PIDrug
Continue on current dual boosted PI until week 24. At week 24, participants will be allowed to cross over to the DRV/r arm provided that they have maintained virologic suppression (< 400 copies/ml) for the first 24-weeks of the study and be followed for an additional 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Switch to DRV/r | Active comparator | Switch to DRV/r at a dose of 600/100 BID for 48 weeks Receives: Drug: Darunavir (DRV/r) |
| Continue on Current Dual Boosted PI | Active comparator | Continue on current dual boosted PI until week 24. At week 24, participants will be allowed to cross over to the DRV/r arm provided that they have maintained virologic suppression (< 400 copies/ml) for the first 24-weeks of the study and are followed for an additional 24 weeks Receives: Drug: continue on current dual boosted PI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Participants With Successful Virologic Suppression
Amount of HIV RNA copies per ml blood collected from subjects as measured by the Ultra-sensitive HIV-1 PCR (Roche Cobas). Successful virologic suppression is defined as < 50 copies/ml blood. The result is the percentage of participants with successful virologic suppression.
Measured: 24 weeks
Secondary outcomes (3)
Economic Impact of a Substitution of Dual Boosted PIs With DRV/r
To assess the economic impact of DRV/r substitution for dual boosted PIs, we compared the average wholesale acquisition costs for the drugs in US Dollars ($) per month. The wholesale acquisition cost in US dollars ($) for each ART regimen was determined and the difference between the cost for the experimental and control groups was calculated and reported as US dollar savings per month.
Measured: 48 weeks
Lipid Fraction Results, Mean of the Change From Baseline to Week 24.
We collected fasting total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides from all participants in both arms of the study. We calculated the differences between the values at week 24 and baseline for the participants in both arms. We reported the mean of the change from baseline to week 24.
Measured: baseline and 24 weeks
Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now)
Participants in the experimental arm completed treatment satisfaction questionnaires at 24 weeks, and the control arm at 48 weeks (24 weeks after mid-study crossover to boosted darunavir). The questionnaires used numeric satisfaction scales (+3 much more satisfied now to -3 much less satisfied now). We reported the median and ranges for each question for each study arm.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Community Research Initiative of New England
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Calvin J Cohen, MD, MSc, Principal investigator, CRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543101
- Sponsor's protocol ID
- 07-142
- Acronym
- DVD
- Status last verified
- Jul 2017
- First submitted
- 11 Oct 2007
- Last updated
- 21 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial to Evaluate the Efficacy of Substituting Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors in Individuals With Virologic Suppression for at Least 12 Weeks
- ClinicalTrials.gov ID
- NCT00543101
- Acronym / sponsor ID
- DVD / 07-142
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS, darunavir, Protease inhibitors, Dual boosted, Treatment experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Community Research Initiative of New EnglandUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 12 Oct 2007 (estimated)
- Results
- Posted 17 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate patients who have achieved virologic suppression (< 400 copies/mL) on any dual protease inhibitor (PI) combination, to determine whether patients can substitute both PIs with the single boosted PI darunavir given 600/100 ritonavir (RTV) twice daily (BID) and maintain comparable virologic suppression (% < 50 c/mL) for 24 weeks.
Detailed description
The purpose of this study is to determine if patients who have achieved virologic suppression (< 400 copies/mL) on any dual PI combination, can substitute both PIs with the single boosted PI darunavir given 600/100 rtv bid and maintain comparable virologic suppression (% < 50 c/mL) for 24 weeks. Randomized, non-blinded, multicenter, 48 week, controlled trial to assess the non-inferiority of substituting DRV/r for a dual boosted PI combination in patients with stable virologic suppression on a regimen containing a dual boosted PI combination plus at least one additional FDA-licensed antiretroviral agent from another class. Participants will be randomized (1:1) to one of the included treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Switch to DRV/r | Active comparator | Drug: Darunavir (DRV/r)Switch to DRV/r at a dose of 600/100 BID for 48 weeks |
| Continue on Current Dual Boosted PI | Active comparator | Drug: continue on current dual boosted PIContinue on current dual boosted PI until week 24. At week 24, participants will be allowed to cross over to the DRV/r arm provided that they have maintained virologic suppression (< 400 copies/ml) for the first 24-weeks of the study and are followed for an additional 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Treatment with a stable antiretroviral regimen containing two protease inhibitors, one additional FDA-licensed agent from another class (except NNRTIs) and a boosting dosage of ritonavir (100 BID or QD) for at least 12 weeks prior to screening
- No plans to make any changes in HIV treatment regimen (other than those required by study) in the next 48 weeks.
- HIV-1 RNA < 400 copies/ml based on the most recent value done as part of routine care at least 12 weeks prior to screening; and < 400 at screening
- Any CD4 count is allowed
Key exclusion criteria (18 listed)
- Current regimen includes an NNRTI
- CDC Class C Illness diagnosed within 30 days of screening
- Lab abnormalities as defined by a standardized grading scheme based on the DAIDS table
- Any grade 3 or 4 toxicity with the following exceptions:
- Clinical or laboratory evidence of clinically significant liver impairment/dysfunction, disease or cirrhosis Note: Individuals co-infected with chronic hepatitis B or C will be allowed to enter the trial if their condition is clinically stable. Individuals diagnosed with acute viral hepatitis at screening will not be allowed to enroll during acute phase.
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 |
|---|---|---|
| Darunavir (DRV/r)Switch to DRV/r at a dose of 600/100 BID for 48 weeks | Drug | Switch to DRV/r |
| continue on current dual boosted PIContinue on current dual boosted PI until week 24. At week 24, participants will be allowed to cross over to the DRV/r arm provided that they have maintained virologic suppression (< 400 copies/ml) for the first 24-weeks of the study and be followed for an additional 24 weeks | Drug | Continue on Current Dual Boosted PI |
Primary outcome
The Percentage of Participants With Successful Virologic Suppression
Time frame: 24 weeks
Amount of HIV RNA copies per ml blood collected from subjects as measured by the Ultra-sensitive HIV-1 PCR (Roche Cobas). Successful virologic suppression is defined as < 50 copies/ml blood. The result is the percentage of participants with successful virologic suppression.
3 secondary outcomes
Economic Impact of a Substitution of Dual Boosted PIs With DRV/r
Time frame: 48 weeks
Lipid Fraction Results, Mean of the Change From Baseline to Week 24.
Time frame: baseline and 24 weeks
Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now)
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Web page of CRI, the nonprofit research group sponsoring the studyLink 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.
Calvin J Cohen, MD, MSc principal investigator
CRI
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Darunavir (DRV/r) and continue on current dual boosted PI in people with HIV Infections, run by Community Research Initiative of New England at 5 sites 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 6 inclusion and 18 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 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 17 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Percentage of Participants With Successful Virologic Suppression (time frame: 24 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 21 Jul 2017.