HIV InfectionsPhase 2NCT00623597

A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.

A Phase 2 study testing ritonavir and saquinavir [Invirase] in people with HIV Infections, run by Hoffmann-La Roche at 10 sites in 3 countries.

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 4 months to 6 years
Conditions the study is for: HIV Infections
What is being tested?: ritonavir and saquinavir [Invirase]
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 10 sitesin 3 countries
Study dates: Jun 2008to Mar 2010
Phase: Phase 2
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 4 months to 6 years
All sexes
No healthy volunteers
Child

Who may be able to join

infants and children, 4 months to <6 years;
confirmed HIV-1 infection;
patients for whom saquinavir/ritonavir together with >=2 background ARVs is considered appropriate.

Who cannot join

body weight >4kg/8.8 pounds;
use of any concomitant medications that may interfere with the pharmacokinetics of saquinavir or ritonavir;
malabsorption, severe chronic diarrhea or vomiting within 28 days of the study.

Trial locations and contacts

10 sites in 3 countries.

Country

City, postcode or hospital

10 sites in 3 countries

Thailand4 sites

Study site
Bangkok, 10400
Study site
Khon Kaen, 40002
Study site
Pathumwan, 10330
Study site
Payathai, 10400

Other trials in Thailand

Argentina3 sites

Study site
Buenos Aires, 1202
Study site
Buenos Aires, 1425
Study site
Santa Fe, 3000

Other trials in Argentina

Spain3 sites

Study site
Madrid, Madrid, 28046
Study site
Madrid, Madrid, 28905
Study site
Valencia, Valencia, 46009

Other trials in Spain

About this study

Official title: A Phase I/II Study of Invirase® Boosted With Ritonavir in HIV Infected Infants and Children 4 Months to Less Than 6 Years Old

This single arm study will assess the pharmacokinetics, safety and activity of saquinavir (Invirase hard gel capsules, film coated tablets or opened capsules) boosted by combination with ritonavir, in HIV-1 infected infants and children between the ages of 4 months and 6 years. Patients will commence treatment with saquinavir 50mg/kg bid plus ritonavir 2.5mg/kg or 3.0mg/kg (dependent on body weight), and a background antiretroviral regimen. If drug exposures are found to be dissimilar to those previously seen in older children and adults, or are associated with toxicities, subsequent dose adjustments will be made. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Conditions: HIV Infections
Being tested: ritonavir, saquinavir [Invirase]
Medical subject headings: HIV Infections

What participants receive

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

ritonavirDrug
2.5-3.0mg/kg po bid (starting dose) for 48 weeks
saquinavir [Invirase]Drug
50mg/kg po bid (starting dose) for 48 weeks

Study groups in NCT00623597
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: ritonavir; Drug: saquinavir [Invirase]

What is being measured

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

Plasma Trough Concentrations (Ctrough) for Saquinavir
Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Saquinavir was normalized to a dose of 50 mg/kg.
Measured: Pre-dose at Weeks 8, 12, 24.
Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir
The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of saquinavir was normalized to a dose of 50 mg/kg.
Measured: Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an Non-nucleoside reverse transcriptase inhibitor [NNRTI] containing regimen).
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes
Measured: From Baseline (Day 1) till Week 48 and Follow-up (Week 52)
Change In Hematocrit From Baseline
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline (Day 1), Week 24 and Week 48
Change In Hemoglobin, Total Protein And Total Albumin From Baseline
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline (Day 1), Week 24 and Week 48
Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline (Day 1), Week 24 and Week 48
Change In Red Blood Cell (RBC) Counts From Baseline
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline (Day 1), Week 24 and Week 48
Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline (Day 1), Week 24 and Week 48
Change In Total Bilirubin, Creatinine, Uric Acid From Baseline
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline (Day 1), Week 24 and Week 48
Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline (Day 1), Week 24 and Week 48
Change In Hematuria, Glycosuria And Proteinuria From Baseline
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline (Day 1), Week 24 and Week 48

Secondary outcomes (10)

Plasma Trough Concentrations (Ctrough) for Ritonavir
Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Ritonavir was normalized to a dose of 100 mg/kg.
Measured: Pre-dose at Weeks 8, 12, 24
Maximum Observed Concentration (Cmax) for Saquinavir and Ritonavir
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was normalized to a dose of 50 mg/kg for Saquinavir and100 mg/kg for Ritonavir.
Measured: Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen and at Week 24
Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Ritonavir
The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of ritonasvir was normalized to a dose of 100 mg/kg.
Measured: Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen).
Change From Baseline in Mean Human Immunodeficiency Virus Viral Load
Change from baseline in plasma HIV-1 RNA was derived as Change from baseline = Log10 (HIV-1 RNA at week x) - Log10 (HIV-1 RNA at baseline)
Measured: Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.
Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <400 Copies/mL
The number of participants with HIV-1 RNA results <400 copies/mL were reported
Measured: Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.
Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <50 Copies/mL
The number of participants with HIV-1 RNA results <50 copies/mL were reported.
Measured: Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.
Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA )
The number of participants experiencing a greater than 1 log drop from baseline (day 1) (log 10 transformed) were reported
Measured: From Week 8 till Week 48
Number of Participants With Virological Failure
Virological failure was defined as: viral load >= 400 copies/mL on two consecutive occasions (missing visits was assumed to be above 400 copies/mL). The number of participants classified as virological failure by Age Group and viral load (≤ 10,000 copies, >10,000 copies) were presented.
Measured: From Week 12 till Week 48
Change From Baseline in Cluster Differentiation Antigen 4 (CD4) Lymphocyte Count
Change from Baseline in CD4+ lymphocyte count at 24 weeks and 48 weeks were presented by age group. Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at week 24/48) - (CD4+ count at baseline). A baseline collection was made if there was not already a value available taken within the previous 4 weeks. Baseline was on Day 1.
Measured: Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation
Change From Baseline in Cluster Differentiation Antigen 8 (CD8) Lymphocyte Count
Change from baseline in CD8+ lymphocyte count at 24 weeks and 48 weeks were presented by age group. Change from baseline in CD8+ lymphocyte count was derived as follows: Change from baseline = (CD8+ count at week 24/48) - (CD8+ count at baseline). A baseline collection was made if there was not already a value available taken within the previous 4 weeks. Baseline was on Day 1.
Measured: Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation

Timeline

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

Jun 2008Mar 2010

First posted26 Feb 2008 (estimated)
Study startJun 2008
Primary completionMar 2010
Study completionMar 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.
More trials run by Hoffmann-La RocheThe 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00623597
Sponsor's protocol ID: NV20911
Other IDs: 2007-004617-34
Status last verified: Feb 2016
First submitted: 18 Feb 2008
Last updated: 7 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes

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?

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Study of Invirase® Boosted With Ritonavir in HIV Infected Infants and Children 4 Months to Less Than 6 Years Old
ClinicalTrials.gov ID: NCT00623597
Acronym / sponsor ID: NV20911
Conditions: HIV Infections
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 26 Feb 2008 (estimated)
Results: Posted 14 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: ritonavir, Drug: saquinavir [Invirase]

Who may qualify

Ages: 4 months to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

infants and children, 4 months to <6 years;
confirmed HIV-1 infection;
patients for whom saquinavir/ritonavir together with >=2 background ARVs is considered appropriate.

Key exclusion criteria (3 listed)

body weight >4kg/8.8 pounds;
use of any concomitant medications that may interfere with the pharmacokinetics of saquinavir or ritonavir;
malabsorption, severe chronic diarrhea or vomiting within 28 days of the study.

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
ritonavir2.5-3.0mg/kg po bid (starting dose) for 48 weeks	Drug	1
saquinavir [Invirase]50mg/kg po bid (starting dose) for 48 weeks	Drug	1

Primary outcome

Plasma Trough Concentrations (Ctrough) for Saquinavir
Time frame: Pre-dose at Weeks 8, 12, 24.
Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Saquinavir was normalized to a dose of 50 mg/kg.
Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir
Time frame: Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an Non-nucleoside reverse transcriptase inhibitor [NNRTI] containing regimen).
The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of saquinavir was normalized to a dose of 50 mg/kg.
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: From Baseline (Day 1) till Week 48 and Follow-up (Week 52)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes
Change In Hematocrit From Baseline
Time frame: Baseline (Day 1), Week 24 and Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change In Hemoglobin, Total Protein And Total Albumin From Baseline
Time frame: Baseline (Day 1), Week 24 and Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline
Time frame: Baseline (Day 1), Week 24 and Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change In Red Blood Cell (RBC) Counts From Baseline
Time frame: Baseline (Day 1), Week 24 and Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline
Time frame: Baseline (Day 1), Week 24 and Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change In Total Bilirubin, Creatinine, Uric Acid From Baseline
Time frame: Baseline (Day 1), Week 24 and Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline
Time frame: Baseline (Day 1), Week 24 and Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change In Hematuria, Glycosuria And Proteinuria From Baseline
Time frame: Baseline (Day 1), Week 24 and Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

10 secondary outcomes

Plasma Trough Concentrations (Ctrough) for Ritonavir
Time frame: Pre-dose at Weeks 8, 12, 24
Maximum Observed Concentration (Cmax) for Saquinavir and Ritonavir
Time frame: Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen and at Week 24
Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Ritonavir
Time frame: Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen).
Change From Baseline in Mean Human Immunodeficiency Virus Viral Load
Time frame: Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.
Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <400 Copies/mL
Time frame: Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.
Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <50 Copies/mL
Time frame: Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.
Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA )
Time frame: From Week 8 till Week 48
Number of Participants With Virological Failure
Time frame: From Week 12 till Week 48
Change From Baseline in Cluster Differentiation Antigen 4 (CD4) Lymphocyte Count
Time frame: Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation
Change From Baseline in Cluster Differentiation Antigen 8 (CD8) Lymphocyte Count
Time frame: Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation

Results and safety

Results posted to the registry on 14 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A	5	4
Group B	13	13

Primary outcome: Plasma Trough Concentrations (Ctrough) for Saquinavir

Time frame: Pre-dose at Weeks 8, 12, 24.. Mean (Standard Deviation). Unit: ng/mL

Measure	Group A n = 5	Group B n = 13
Value	645 (536)	1860 (1060)

Population analysed: The pharmacokinetics Analysis Population (PKP) comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.

Primary outcome: Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir

Time frame: Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an Non-nucleoside reverse transcriptase inhibitor [NNRTI] containing regimen).. Mean (Standard Deviation). Unit: h*ug/mL

Measure	Group A n = 5	Group B n = 13
Value	18.7 (20.0)	38 (18.1)

Primary outcome: Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)

Time frame: From Baseline (Day 1) till Week 48 and Follow-up (Week 52). Number. Unit: participants

Measure	Group A n = 5	Group B n = 13	Total n = 18
Any serious adverse events	1	2	3
Any non-serious adverse events	5	9	14

Population analysed: The Safety Analysis Population (SAP) comprised all participants who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.

Primary outcome: Change In Hematocrit From Baseline

Time frame: Baseline (Day 1), Week 24 and Week 48. Mean (Standard Deviation). Unit: fraction

Measure	Group A n = 5	Group B n = 13	Total n = 18
Change from Baseline at Week 24 (n= 4, 13, 17)	0.01 (0.011)	-0 (0.03)	-0 (0.027)
Change from Baseline at Week 48 (n= 4, 13, 17)	0.03 (0.037)	-0.01 (0.044)	0 (0.044)

Population analysed: The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 56 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A	1 of 5 (20%)	5 of 5 (100%)	Not reported
Group B	2 of 13 (15.4%)	9 of 13 (69.2%)	Not reported
Total	3 of 18 (16.7%)	14 of 18 (77.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

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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.

Clinical Trials study director

Hoffmann-La Roche

10 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ritonavir and saquinavir [Invirase] in people with HIV Infections, run by Hoffmann-La Roche at 10 sites in 3 countries.

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 3 inclusion and 3 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 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Thailand, Argentina, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 14 Jan 2016). 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?

Plasma Trough Concentrations (Ctrough) for Saquinavir (time frame: Pre-dose at Weeks 8, 12, 24.). The study lists 11 primary outcomes in all. 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 NCT00623597.

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 7 Mar 2016.