HIV InfectionsPhase 4NCT00379405
Saquinavir/Ritonavir in Single Therapy as Maintenance Treatment
A Phase 4 study testing Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours in people with HIV Infections, run by Germans Trias i Pujol Hospital at 2 sites in Spain.
Trial summary
Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance therapy, compared to standard HAART therapies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- Jun 2006to Jul 2008
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients infected by HIV-1 (at least one documented positive Western-Blot).
- Age > 18 years.
- Patients on antiretroviral treatment (standard HAART therapy) for at least six months.
- HIV-1 plasma viral load <50 copies/mL (documented in at least two determinations performed over the six months prior to the inclusion visit).
- Patients without evidence of previous virological failure to IP
- Absence of opportunistic infections and/or tumours in the three months prior to inclusion.
- Subject able to follow the treatment period, without any suspicion of poor adherence during previous antiretroviral treatments.
- Signature of the informed consent.
Who cannot join
- Suspicion of unsuitable antiretroviral treatment compliance.
- Documented existence of any of the primary mutations in the protease gene or 3 or more of the following: L10F/I/R/V, K20M/R, M36I/V, I54L/T/V, L63P, A71T/V , V82A/F/T/S, I84A/V OR L90M.
- Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
- Hepatic tests (AST, ALT, GGT) > or equal to 5 times the upper limit of normality during the three months prior to the screening visit
- Presence of renal impairment (creatinine > or equal to 1.5 times the upper limit of normality).
- Pregnancy or breastfeeding. Refusal to use reliable contraceptive methods during the study period.
- Participation in another clinical trial wich entail the antiretroviral treatment modification.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Germans Trias i Pujol University Hospital
Badalona, Barcelona, 08916
Hospital del Sant Pau.
Barcelona, 08025
About this study
Official title: Open-label, Comparative and Randomised Pilot Study to Evaluate the Efficacy and Safety of Saquinavir/Ritonavir in Single Therapy vs Standard HAART Therapy as Maintenance Therapy.
Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance therapy, compared to standard HAART therapies.
Read the detailed description
Different therapeutic strategies have been investigated to improve adherence to treatment and reduce toxicity. Both the reduction in the number of doses and the number of daily tablets have led to an improvement in therapeutic compliance. Similarly, the administration of new treatment regimens with a reduced number of tablets a day and without NTRI may be clinically useful in improving compliance with HAART and limiting NTRI-associated toxicity. These would comprise combinations of a PI, boosted with ritonavir, plus a non-Nucleoside and single therapy with PIs boosted with ritonavir.
In this regard, the results obtained with lopinavir/ritonavir and with atazanavir/ritonavir are very promising and open up a possible channel of research with other PIs boosted with low doses of ritonavir.
There are other PIs whose antiretroviral efficacy has also been demonstrated, such as saquinavir, but whose economic cost is much lower. Furthermore, saquinavir has a low toxicity profile, and the availability of saquinavir 500 mg facilitates comfortable administration, since it makes it possible to reduce the number of daily tablets to more than half.
Moreover, it is important to take into account that the incidence of mutations that confer resistance to saquinavir on patients that fail on combinations including this PI is very low, which makes it possible to reuse the drug in future treatment regimens or salvage patients with other PI All these characteristics (high intrinsic potency, low number of tablets, low toxicity, low potential of selection of resistant viral strains in combination with ritonavir, and low economic cost) make single therapy with the new formulation of saquinavir, boosted with low doses of ritonavir, a possible therapeutic option as maintenance strategy in HIV-infected patients with maintained suppression of the viral load.
- Conditions
- HIV Infections
- Being tested
- Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours
- Keywords
- Saquinavir/ritonavir, Single therapy, Virological efficacy, Safety, HIV-1
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hoursDrug
Also called Invirase
Saquinavir/Ritonavir: 2 capsules (500 mg) / 12 hours
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Saquinavir (Invirase): 2 capsules (500 mg) / 12 hours Receives: Drug: Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours |
| 2 | No intervention | IP o NNUCS + 2 NUCS as a HAART therapy . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virological response: Viral Load
Measured: weeks 24 and 48
Secondary outcomes (10)
CD4 and CD8 lymphocyte count.
Measured: weeks 24 and 48
Physical Exploration: including weight, height, index waist/hip (the abdominal perimeter is measured between the last floating rib and the iliac crest), assessment of changes in body fat distribution,...
Measured: weeks 24 and 48
Karnofsky Index.
Measured: weeks 24 and 48
Adverse events.
Measured: during the 48 weeks of follow-up
Trough plasma concentrations of Saquinavir.
Measured: during the 48 weeks of follow-up
Lipid study in plasma (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides)
Measured: during the 48 weeks of follow-up
Serology for Hepatitis B and C virus.
Measured: at baseline visit
Assessment of treatment adherence.
Measured: at baseline and weeks 4, 12, 24, 36 and 48
Assessment of quality of life (by means of the MOS-HIV questionnaire).
Measured: at baseline and weeks 4, 12, 24, 36 and 48
Genotype if virological failure.
Measured: at any time of study if it is necessary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startJun 2006
- Primary completionMay 2008
- Study completionJul 2008
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Responsible party
- Sponsor
- Investigators
- Clotet Bonaventura, MD,PhD, Principal investigator, Hospital Universitari Germans Trias i Pujol. Badalona (Barcelona)Negredo Eugenia, MD,PhD, Principal investigator, Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)Echeverria Patricia, MD,PhD, Principal investigator, Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)Molto Jose, MD,PhD, Principal investigator, Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)Pere Domingo, MD, PhD, Principal investigator, Hospital de Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379405
- Sponsor's protocol ID
- SQV/RTV-MONOTERAPIA
- Other IDs
- 2006-001136-47
- Status last verified
- Dec 2019
- First submitted
- 20 Sep 2006
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Comparative and Randomised Pilot Study to Evaluate the Efficacy and Safety of Saquinavir/Ritonavir in Single Therapy vs Standard HAART Therapy as Maintenance Therapy.
- ClinicalTrials.gov ID
- NCT00379405
- Acronym / sponsor ID
- SQV/RTV-MONOTERAPIA
- Conditions
- HIV Infections
- Keywords
- Saquinavir/ritonavir, Single therapy, Virological efficacy, Safety, HIV-1
- 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
- Jun 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 21 Sep 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.
Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance therapy, compared to standard HAART therapies.
Detailed description
Different therapeutic strategies have been investigated to improve adherence to treatment and reduce toxicity. Both the reduction in the number of doses and the number of daily tablets have led to an improvement in therapeutic compliance. Similarly, the administration of new treatment regimens with a reduced number of tablets a day and without NTRI may be clinically useful in improving compliance with HAART and limiting NTRI-associated toxicity. These would comprise combinations of a PI, boosted with ritonavir, plus a non-Nucleoside and single therapy with PIs boosted with ritonavir.
In this regard, the results obtained with lopinavir/ritonavir and with atazanavir/ritonavir are very promising and open up a possible channel of research with other PIs boosted with low doses of ritonavir.
There are other PIs whose antiretroviral efficacy has also been demonstrated, such as saquinavir, but whose economic cost is much lower. Furthermore, saquinavir has a low toxicity profile, and the availability of saquinavir 500 mg facilitates comfortable administration, since it makes it possible to reduce the number of daily tablets to more than half.
Moreover, it is important to take into account that the incidence of mutations that confer resistance to saquinavir on patients that fail on combinations including this PI is very low, which makes it possible to reuse the drug in future treatment regimens or salvage patients with other PI All these characteristics (high intrinsic potency, low number of tablets, low toxicity, low potential of selection of resistant viral strains in combination with ritonavir, and low economic cost) make single therapy with the new formulation of saquinavir, boosted with low doses of ritonavir, a possible therapeutic option as maintenance strategy in HIV-infected patients with maintained suppression of the viral load.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hoursSaquinavir (Invirase): 2 capsules (500 mg) / 12 hours |
| 2 | No intervention | –IP o NNUCS + 2 NUCS as a HAART therapy . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients infected by HIV-1 (at least one documented positive Western-Blot).
- Age > 18 years.
- Patients on antiretroviral treatment (standard HAART therapy) for at least six months.
- HIV-1 plasma viral load <50 copies/mL (documented in at least two determinations performed over the six months prior to the inclusion visit).
- Patients without evidence of previous virological failure to IP
Key exclusion criteria (7 listed)
- Suspicion of unsuitable antiretroviral treatment compliance.
- Documented existence of any of the primary mutations in the protease gene or 3 or more of the following: L10F/I/R/V, K20M/R, M36I/V, I54L/T/V, L63P, A71T/V , V82A/F/T/S, I84A/V OR L90M.
- Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
- Hepatic tests (AST, ALT, GGT) > or equal to 5 times the upper limit of normality during the three months prior to the screening visit
- Presence of renal impairment (creatinine > or equal to 1.5 times the upper limit of normality).
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 |
|---|---|---|
| Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hoursAlso: InviraseSaquinavir/Ritonavir: 2 capsules (500 mg) / 12 hours | Drug | A |
Primary outcome
Virological response: Viral Load
Time frame: weeks 24 and 48
10 secondary outcomes
CD4 and CD8 lymphocyte count.
Time frame: weeks 24 and 48
Physical Exploration: including weight, height, index waist/hip (the abdominal perimeter is measured between the last floating rib and the iliac crest), assessment of changes in body fat distribution,...
Time frame: weeks 24 and 48
Karnofsky Index.
Time frame: weeks 24 and 48
Adverse events.
Time frame: during the 48 weeks of follow-up
Trough plasma concentrations of Saquinavir.
Time frame: during the 48 weeks of follow-up
Lipid study in plasma (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides)
Time frame: during the 48 weeks of follow-up
Serology for Hepatitis B and C virus.
Time frame: at baseline visit
Assessment of treatment adherence.
Time frame: at baseline and weeks 4, 12, 24, 36 and 48
Assessment of quality of life (by means of the MOS-HIV questionnaire).
Time frame: at baseline and weeks 4, 12, 24, 36 and 48
Genotype if virological failure.
Time frame: at any time of study if it is necessary
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 4 Dec 2019.
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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.
Clotet Bonaventura, MD,PhD principal investigator
Hospital Universitari Germans Trias i Pujol. Badalona (Barcelona)
Negredo Eugenia, MD,PhD principal investigator
Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)
Echeverria Patricia, MD,PhD principal investigator
Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)
2 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 Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours in people with HIV Infections, run by Germans Trias i Pujol Hospital at 2 sites in Spain.
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 8 inclusion and 7 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 4 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 2 sites 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?
Virological response: Viral Load (time frame: weeks 24 and 48). 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 4 Dec 2019.