HIV InfectionsPhase 4DRV900100QDNCT00611039

Evaluate the Efficacy and Security of Darunavir/Ritonavir 900/100 mg Once a Day as an Antiretroviral Treatment Simplification Strategy

A Phase 4 study testing Darunavir 900mg + ritonavir 100 mg once a day and Darunavir 600mg + ritonavir 100mg twice day in people with HIV Infections, run by Germans Trias i Pujol Hospital at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: Darunavir 900mg + ritonavir 100 mg once a day and Darunavir 600mg + ritonavir 100mg twice day
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSpain
Study dates: Feb 2008to Jul 2009
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

Age >= 18 years.
HIV-infected patients.
Stable antiretroviral treatment including darunavir/ritonavir 600/100 every 12 hours for at least 4 weeks.
HIV viral load < 50 copies/mL for at least 12 weeks.
Resistance test (Genotype or Virtual Phenotype) before starting tipranavir treatment.
Darunavir vIQ >= 2.

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Subject able to follow the treatment period.
In women, negative pregnancy test or not in fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or undertaking to use a barrier contraceptive method during the study.
Signature of the informed consent.

Who cannot join

AIDS-defining illness in the last 4 weeks.
Suspicion of unsuitable antiretroviral treatment compliance.
In women, pregnancy or breastfeeding.
Record or suspicion of incapability to cooperate as appropriate.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Germans Trias i Pujol Hospital
Badalona, Barcelona, 08916

Other trials in Spain

About this study

Official title: Clinical Pilot, Open, Comparative and Randomized Trial to Evaluate the Efficacy and Security of Darunavir/Ritonavir 900/100 mg Once a Day as an Antiretroviral Treatment Simplification Strategy

Basing in studies which have related the darunavir (DRV) virtual inhibitory quotient (vIQ) with the virological response, it is possible to think in the possibility of simplifying the rescue treatment with DRV/ritonavir to 900/100 mg once a day in those patients who are being treated with DRV/ritonavir 600/100 mg twice a day and who, besides having undetectable viral load, have a vIQ over 2. This strategy would not jeopardize the efficacy of the antiretroviral treatment and would have less impact in the lipid profile of the patients as well as less pharmaceutical expenditure.

Read the detailed description

The probability of achieving viral replication suppression during the treatment with DRV has been related to both the extent of viral resistance to DRV (inhibitory concentration 50%, IC50) and the drug concentration. Moreover, the DRV virtual inhibitory quotient (vIQ) has been related significantly with the virological response to DRV treatment. So patients with a DRV vIQ >= 1,5 had a 8-times higher probability of having viral load < 50 copies/mL after 24 weeks of treatment than those having a vIQ < 1,5.

Considering the previous arguments, it is possible to think in the possibility of simplifying the rescue treatment with DRV/ritonavir to 900/100 mg once a day in those patients who are being treated with DRV/ritonavir 600/100 mg twice a day and who, besides having undetectable viral load, have a DRV vIQ over 2. This strategy would not jeopardize the efficacy of the antiretroviral treatment and would have less impact in the lipid profile of the patients as well as less pharmaceutical expenditure.

Conditions: HIV Infections
Being tested: Darunavir 900mg + ritonavir 100 mg once a day, Darunavir 600mg + ritonavir 100mg twice day
Keywords: Darunavir/ritonavir, virtual inhibitory quotient, dose reduction
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Darunavir 900mg + ritonavir 100 mg once a dayDrug
Darunavir 900mg + ritonavir 100 mg once a day
Darunavir 600mg + ritonavir 100mg twice dayDrug
Darunavir 600mg + ritonavir 100mg twice day

Study groups in NCT00611039
Study group	Role	What they receive
1	Experimental	Darunavir 900mg + ritonavir 100 mg once a day Receives: Drug: Darunavir 900mg + ritonavir 100 mg once a day
2	Active comparator	Darunavir 600mg + ritonavir 100mg twice day Receives: Drug: Darunavir 600mg + ritonavir 100mg twice day

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of patients with HIV-1 viral load < 50 copies /mL
Measured: Basal, week 2, week 4, week 8, week 12 ,week 24week 36 and week 48

Secondary outcomes (9)

DRV plasma trough concentration
Measured: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
DRV Virtual inhibitory quotient (vIQ)
Measured: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
CD4 and CD8 lymphocytes count
Measured: Screening, Basal, week 12, week 24, week 36 and week 48
Physical examination including weight and height
Measured: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Karnofsky index
Measured: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week, 36 and week 48
Adverse events
Measured: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Lipid profile (total cholesterol, HDL-cholesterol. LDL-cholesterol and triglycerides)
Measured: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Treatment adherence (assessed by the physician, but not recovered in the data base)
Measured: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Genotype, if virological failure occurs
Measured: When virological failure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Jul 2009

First posted8 Feb 2008 (estimated)
Study startFeb 2008
Primary completionJul 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00611039
Sponsor's protocol ID: DRV 900100 QD
Acronym: DRV900100QD
Status last verified: Dec 2019
First submitted: 28 Jan 2008
Last updated: 5 Dec 2019
Results posted: No
Data monitoring committee: No

Publications

Molto J, Valle M, Santos JR, Mothe B, Miranda C, Cedeno S, Negredo E, Yritia M, Videla S, Barbanoj MJ, Clotet B. Treatment simplification to once daily darunavir/ritonavir guided by the darunavir inhibitory quotient in heavily pretreated HIV-infected patients. Antivir Ther. 2010;15(2):219-25. doi: 10.3851/IMP1519.
PubMed 20386077

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Pilot, Open, Comparative and Randomized Trial to Evaluate the Efficacy and Security of Darunavir/Ritonavir 900/100 mg Once a Day as an Antiretroviral Treatment Simplification Strategy
ClinicalTrials.gov ID: NCT00611039
Acronym / sponsor ID: DRV900100QD / DRV 900100 QD
Conditions: HIV Infections
Keywords: Darunavir/ritonavir, virtual inhibitory quotient, dose reduction
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Germans Trias i Pujol HospitalUniversity, hospital or other
Collaborators: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Study start: Feb 2008
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 8 Feb 2008 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Darunavir 900mg + ritonavir 100 mg once a dayDarunavir 900mg + ritonavir 100 mg once a day
2	Active comparator	Drug: Darunavir 600mg + ritonavir 100mg twice dayDarunavir 600mg + ritonavir 100mg twice day

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age >= 18 years.
HIV-infected patients.
Stable antiretroviral treatment including darunavir/ritonavir 600/100 every 12 hours for at least 4 weeks.
HIV viral load < 50 copies/mL for at least 12 weeks.
Resistance test (Genotype or Virtual Phenotype) before starting tipranavir treatment.

Key exclusion criteria (4 listed)

AIDS-defining illness in the last 4 weeks.
Suspicion of unsuitable antiretroviral treatment compliance.
In women, pregnancy or breastfeeding.
Record or suspicion of incapability to cooperate as appropriate.

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 900mg + ritonavir 100 mg once a dayDarunavir 900mg + ritonavir 100 mg once a day	Drug	1
Darunavir 600mg + ritonavir 100mg twice dayDarunavir 600mg + ritonavir 100mg twice day	Drug	2

Primary outcome

Proportion of patients with HIV-1 viral load < 50 copies /mL
Time frame: Basal, week 2, week 4, week 8, week 12 ,week 24week 36 and week 48

9 secondary outcomes

DRV plasma trough concentration
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
DRV Virtual inhibitory quotient (vIQ)
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
CD4 and CD8 lymphocytes count
Time frame: Screening, Basal, week 12, week 24, week 36 and week 48
Physical examination including weight and height
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Karnofsky index
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week, 36 and week 48
Adverse events
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Lipid profile (total cholesterol, HDL-cholesterol. LDL-cholesterol and triglycerides)
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Treatment adherence (assessed by the physician, but not recovered in the data base)
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Genotype, if virological failure occurs
Time frame: When virological failure

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 Dec 2019.
Derived from this study: PubMed 20386077Molto J, Valle M, Santos JR, Mothe B, Miranda C, Cedeno S, Negredo E, Yritia M, Videla S, Barbanoj MJ, Clotet B. Treatment simplification to once daily darunavir/ritonavir guided by the darunavir inhibitory quotient in heavily pretreated HIV-infected patients. Antivir Ther. 2010;15(2):219-25. doi: 10.3851/IMP1519.

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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.

Bonaventura Clotet, MD,PhD principal investigator

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 4 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 Dec 2019. 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 Spain. 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 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?

Proportion of patients with HIV-1 viral load < 50 copies /mL (time frame: Basal, week 2, week 4, week 8, week 12 ,week 24week 36 and week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00611039, which also lists 1 linked publication.

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 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.