CClinicalTrials.gg
Sign In
CompletedNCT01448707PROTEAUpdated Nov 27, 2017Results posted

A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment

A Phase 3 interventional study of Darunavir and Ritonavir in Human Immunodeficiency Virus (HIV) Infections and Acquired Immunodeficiency Syndrome (AIDS) Virus, sponsored by Janssen-Cilag International NV. Completed at 36 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-27.

Sponsored by Janssen-Cilag International NV · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
274
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg monotherapy with a triple combination therapy containing darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) in approximately 260 Human Immunodeficiency Virus-1 (HIV-1) infected patients who have been on Highly Active AntiRetroviral Therapy (HAART) medication and have a plasma Viral Load below 50 copies/mL for at least 48 weeks. Also the changes in neurocognitive function will be compared throughout the study.

Read the detailed description

This is phase IIIb, randomised (study medication is assigned by chance), open-label (both the patient and the study physician will know to which treatment group the patient is assigned) trial to compare the efficacy, safety and tolerability of darunavir/ritonavir (DRV/rtv) 800/100 mg once daily monotherapy with a triple combination therapy containing DRV/rtv 800/100 mg once daily and an investigator-selected background of 2 other anti-HIV drugs of the class nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs). The investigator-selected N[t]RTIs is a dual combination of either be abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC). Approximately 260 HIV-1 infected patients, who have received HAART for at least 48 weeks, have not changed their treatment within the last 8 weeks, and who have documented evidence of plasma viral load (plasma HIV-1 RNA) below 50 copies/mL for at least 48 weeks prior to being screened, participate in the study. The study period includes a screening period of maximum 6 weeks, a 4-week run-in period, a 96 week treatment period, followed by a 4 weeks follow-up period. According to the original protocol, at the start of the 4-week run-in period all patients replaced their 3rd agent (non-nucleoside reverse transcriptase (NNRTI), protease inhibitor (PI) or integrase inhibitor) of the HAART medication with DRV/rtv and continued with the 2 N[t]RTIs. After 4 weeks the patient was randomly assigned (like flipping a coin) to either the monotherapy group or the triple therapy group. If assigned to the monotherapy group, the 2 N[t]RTIs were stopped and only DRV/rtv was continued. If assigned to the triple therapy group, DRV/rtv were continued together with 2 N[t]RTIs, which can be the same as already taken or are switched to new N[t]RTIs. Based on the primary efficacy analysis after Week 48, the protocol was amended such that subjects in the monotherapy arm who entered the study with a nadir CD4+ count of \<200 cells/μL will also receive 2 N[t]RTIs (ie, triple therapy) as soon as possible.

The main purpose of this study is to demonstrate that DRV/rtv monotherapy is as effective as a triple combination therapy containing DRV/rtv and 2N[t]RTIs. In addition, the study looks at overall safety and tolerability between the two treatment groups. During the study, patients' health are monitored by physical examination, checking of vital signs (blood pressure / pulse), and laboratory testing on blood and urine samples. Also blood samples are drawn to measure the antiviral effectiveness (i.e., decrease of the plasma viral load to a level \<50 HIV-1 RNA copies/mL) and immunology assessments (to assess the body's immune system). A battery of neurocognitive function tests is performed during the study visits. A sub-study takes place in selected hospitals. Approximately 100 patients have 2 additional tests done, at the start of the run-in phase and after 48-weeks of randomisation. For this substudy a lumbar puncture (extraction of cerebrospinal fluid [CSF] from the spinal canal) for laboratory testing (antiviral effectiveness, pharmacokinetic analysis, biochemistry and immune markers) and an additional blood sample for pharmacokinetic analysis (to measure the drug level in blood) is taken. The study hypothesis is that, after 48 weeks of randomised treatment, DRV/rtv monotherapy is as effective as the triple therapy containing DRV/rtv plus 2 N[t]RTIs. Two 400 mg tablets of darunavir and one 100 mg tablet ritonavir are taken together once daily orally within 30 minutes after completion of a meal, for 100 weeks. The intake of the investigator-selected N[t]RTIs as according the local prescribing information.

02

Conditions studied

  • Human Immunodeficiency Virus (HIV) Infections
  • Acquired Immunodeficiency Syndrome (AIDS) Virus

Keywords

  • Darunavir (DRV)
  • TMC114
  • Prezista
  • HIV
  • virologic response
  • neurocognitive function
03

In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 274 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Janssen-Cilag International NV is the lead sponsor of 66 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • HIV-1 infection
  • receiving HAART for at least 48 weeks
  • Have at least 2 documented plasma HIV-1 RNA \<50 copies/mL, and no HIV-1 RNA >=50 copies/mL in the 48 weeks prior to the screening
  • Be taking the same antiretroviral (ARV) combination for at least 8 weeks before screening
  • Have the preference, together with the physician, to change the current HAART regimen for reasons of simplification and/or toxicity

Exclusion criteria

Exclusion Criteria:

  • Has a history of virologic failure defined as 2 consecutive plasma HIV-1 RNA >500 copies/mL while on previous or current antiretroviral therapy
  • Has a history of any primary PI mutations
  • Has clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insufficiency)
  • Is diagnosed with acute viral hepatitis at screening or before Baseline 1
  • Is co-infected with hepatitis B
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
274 participants (actual)

Study arms

  • Experimental
    Darunavir monotherapy

    Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal. Following the primary efficacy analysis after Week 48, patients who entered the study with a nadir CD4+ count of \<200 cells/μL will also receive 2 N\[t\]RTIs (ie, triple therapy) as soon as possible

    Drug: Darunavir · Drug: Ritonavir

  • Active comparator
    Triple therapy containing darunavir

    Darunavir (DRV) + ritonavir (rtv) + 2 N\[t\]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N\[t\]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)

    Drug: Darunavir · Drug: Ritonavir

Interventions

  • DrugDarunavir

    Darunavir (DRV): type = exact number, unit = mg, number = 800, form = tablet, route = oral use

  • DrugRitonavir

    ritonavir (rtv): type = exact number, unit = mg, number = 100, form = tablet, route = oral use

06

What researchers measure

Primary outcomes

  1. Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)

    The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels \<50 copies/milliliters \[mL\] after 48 weeks of follow-up. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N\[t\]RTIs) not permitted by the trial protocol or plasma HIV-1 RNA assessment closest to target date of the analysis time point window (44-52 weeks) and next/confirmation of Plasma HIV-1 RNA in the analysis time point window above the threshold or discontinuation for any other reason.

    Time frame: Week 48

Secondary outcomes

  1. Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)

    The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels \<50 copies/milliliters \[mL\] after 96 weeks of follow-up after switching to DRV/ritonavir(rtv) monotherapy versus triple therapy containing DRV/rtv. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N\[t\]RTIs) not permitted by the trial protocol.

    Time frame: Week 96

  2. Virologic Response (FDA Snapshot, Switch Included)

    The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels \<50 copies/milliliters \[mL\] after 48 and 96 weeks of follow-up after switching to DRV/ritonavir(rtv) monotherapy versus triple therapy containing DRV/rtv. Switch included is defined as all participants who discontinued randomized medication were followed up on their subsequent treatment.

    Time frame: Week 48 and 96

  3. Change From Baseline in Global Neurocognitive Performance z-Score

    Change in neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Neurocognitive function will be measured by Hopkins Verbal Learning Test (verbal learning and memory), Colour Trail Test (psychomotor speed and cognitive flexibility) and Grooved Pegboard Test (psychomotor speed and fine motor function). Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP).

    Time frame: Baseline, Week 48 and 96

  4. Time to Loss of Virologic Response

    Time (in days) it takes to show loss of response per time to loss of virologic response (TLOVR) algorithm: confirmed HIV-1 RNA \>= 50 copies/mL or premature discontinuation.

    Time frame: Baseline up to Week 96 or early withdrawal

  5. Number of Participants Reporting Treatment-Emergent Phenotypic Drug Resistance

    The loss of treatment options of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96, as defined by treatment-emergent phenotypic drug resistance. Drug resistance is classified as: 1) Confirmed HIV RNA \>= 400 copies/mL, 2) Post-baseline phenotypic data and 3) Phenotypic resistance to any of the drug classes (NRTI, NNRTI, or PI).

    Time frame: At Weeks 48 and 96

  6. Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results

    The viral genotype of participants treated with DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Genotypic resistance (number of resistance mutations) at any time point when a participant had a confirmed plasma VL \>400 copies/mL after randomization was performed per treatment group for the ITT population. Results were summarized based on individual treatment received: Darunavir resistance mutations, non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations, nucleoside reverse transcriptase inhibitor (NRTI) mutations, protease inhibitor (PI) resistance mutations, PR mutations, RT mutations, extended NNRTI mutations, primary PI mutations.

    Time frame: Over 48 and 96 Weeks

07

Results

Posted Dec 3, 2015

Participant flow

Participant flow — Overall Study
MilestoneDRV/Rtv MONODRV/Rtv + 2NRTIs
Started137136
Completed119118
Not completed1818
Withdrew: Adverse event31
Withdrew: Lost to follow-up26
Withdrew: Withdrawal by subject67
Withdrew: Other74

Outcome measures

PrimaryVirologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)

The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels \<50 copies/milliliters \[mL\] after 48 weeks of follow-up. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N\[t\]RTIs) not permitted by the trial protocol or plasma HIV-1 RNA assessment closest to target date of the analysis time point window (44-52 weeks) and next/confirmation of Plasma HIV-1 RNA in the analysis time point window above the threshold or discontinuation for any other reason.

Time frame:
Week 48
Reported as:
Number · Percentage of Participants
Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)
Percentage of ParticipantsDRV/rDRV/r + 2NRTIs
Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)87.095.0
Statistical analysis
  • DRV/r vs DRV/r + 2NRTIs · Mixed Models Analysis · p = 0.2331 (P-Value for non-inferiority of DRV/rtv MONO vs DRV/rtv + 2NRTIs (delta = 12%).) · Non-linear mixed: -7.9 · 95% CI -14.64 to -1.19Predicted response rate:confidence limits are obtained by means of logistic regression model with treatment group and Hepatitis C status as covariates
SecondaryVirologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)

The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels \<50 copies/milliliters \[mL\] after 96 weeks of follow-up after switching to DRV/ritonavir(rtv) monotherapy versus triple therapy containing DRV/rtv. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N\[t\]RTIs) not permitted by the trial protocol.

Time frame:
Week 96
Reported as:
Number · Percentage of Participants
Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)
Percentage of ParticipantsDRV/rDRV/r + 2NRTIs
Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)75.285.3
Statistical analysis
  • DRV/r vs DRV/r + 2NRTIs · Mixed Models Analysis · p = 0.6933 · Non-linear mixed: -10.1 · 95% CI -19.50 to -0.73
SecondaryVirologic Response (FDA Snapshot, Switch Included)

The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels \<50 copies/milliliters \[mL\] after 48 and 96 weeks of follow-up after switching to DRV/ritonavir(rtv) monotherapy versus triple therapy containing DRV/rtv. Switch included is defined as all participants who discontinued randomized medication were followed up on their subsequent treatment.

Time frame:
Week 48 and 96
Reported as:
Number · Percentage of Participants
Virologic Response (FDA Snapshot, Switch Included)
Percentage of ParticipantsDRV/rDRV/r + 2NRTIs
Week 4893.096.5
Week 9689.389.9
Statistical analysis
  • DRV/r vs DRV/r + 2NRTIs · Mixed Models Analysis · p = 0.0016 · Non-linear mixed model: -3.5 · 95% CI -8.77 to 1.72
  • DRV/r vs DRV/r + 2NRTIs · Mixed Models Analysis · p = 0.0022 · Non-linear mixed model: -0.7 · 95% CI -7.89 to 6.58
SecondaryChange From Baseline in Global Neurocognitive Performance z-Score

Change in neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Neurocognitive function will be measured by Hopkins Verbal Learning Test (verbal learning and memory), Colour Trail Test (psychomotor speed and cognitive flexibility) and Grooved Pegboard Test (psychomotor speed and fine motor function). Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP).

Time frame:
Baseline, Week 48 and 96
Reported as:
Mean · Units on a Scale
Change From Baseline in Global Neurocognitive Performance z-Score
Units on a ScaleDRV/rDRV/r + 2NRTIs
Change at Week 480.39 ± 0.0480.42 ± 0.057
Change at Week 960.63 ± 0.0600.57 ± 0.057
SecondaryTime to Loss of Virologic Response

Time (in days) it takes to show loss of response per time to loss of virologic response (TLOVR) algorithm: confirmed HIV-1 RNA \>= 50 copies/mL or premature discontinuation.

Time frame:
Baseline up to Week 96 or early withdrawal
Reported as:
Median · Days
Time to Loss of Virologic Response
DaysDRV/rDRV/r + 2NRTIs
Time to Loss of Virologic ResponseNA ± 19.92NA ± 18.88
SecondaryNumber of Participants Reporting Treatment-Emergent Phenotypic Drug Resistance

The loss of treatment options of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96, as defined by treatment-emergent phenotypic drug resistance. Drug resistance is classified as: 1) Confirmed HIV RNA \>= 400 copies/mL, 2) Post-baseline phenotypic data and 3) Phenotypic resistance to any of the drug classes (NRTI, NNRTI, or PI).

Time frame:
At Weeks 48 and 96
Reported as:
Number · Participants
Number of Participants Reporting Treatment-Emergent Phenotypic Drug Resistance
ParticipantsDRV/rDRV/r + 2NRTIs
Confirmed HIV RNA >= 400 copies/mL12
Post-baseline phenotypic data21
Phenotypic resistance to any of the drug classes00
SecondaryNumber of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results

The viral genotype of participants treated with DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Genotypic resistance (number of resistance mutations) at any time point when a participant had a confirmed plasma VL \>400 copies/mL after randomization was performed per treatment group for the ITT population. Results were summarized based on individual treatment received: Darunavir resistance mutations, non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations, nucleoside reverse transcriptase inhibitor (NRTI) mutations, protease inhibitor (PI) resistance mutations, PR mutations, RT mutations, extended NNRTI mutations, primary PI mutations.

Time frame:
Over 48 and 96 Weeks
Reported as:
Number · Participants
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results
ParticipantsDRV/rDRV/r + 2NRTIs
Participans with HIV RNA >= 400 copies/mL12
Number of 0 Darunavir resistance mutations21
Number of 0 NNRTI mutations20
Number of 1 NNRTI mutations01
Number of 1 PI resistance mutations10
Number of 5 PI resistance mutations01
Number of 6 PI resistance mutations10
Number of 11 PR mutations01
Number of 15 PR mutations10
Number of 7 PR mutations10
Number of 14 RT mutations10
Number of 16 RT mutations01
Number of 33 RT mutations10
Number of extended 0 NNRTI mutations20
Number of extended 1 NNRTI mutations01
Number of primary 0 PI mutations21
Number of participants with no mutations00

Adverse events

Collected over Baseline up to 96 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
DRV/Rtv MONO—18/137 (13.1%)61/137 (44.5%)
DRV/Rtv + 2NRTIs—14/136 (10.3%)47/136 (34.6%)
Most frequent serious events
Showing 10 of 50
Most frequent serious events
EventDRV/Rtv MONODRV/Rtv + 2NRTIs
Hepatitis CInfections and infestations2/1370/136
PyrexiaGeneral disorders1/1371/136
TendernessGeneral disorders0/1371/136
HypersensitivityImmune system disorders0/1371/136
AbscessInfections and infestations0/1371/136
CellulitisInfections and infestations0/1371/136
Gastroenteritis ViralInfections and infestations0/1371/136
Groin AbscessInfections and infestations0/1371/136
MeningitisInfections and infestations0/1371/136
PyelonephritisInfections and infestations0/1371/136
Most frequent other events
Showing 10 of 11
Most frequent other events
EventDRV/Rtv MONODRV/Rtv + 2NRTIs
DiarrhoeaGastrointestinal disorders18/13710/136
NasopharyngitisInfections and infestations16/13711/136
Back PainMusculoskeletal and connective tissue disorders10/1374/136
HeadacheNervous system disorders8/1379/136
CoughRespiratory, thoracic and mediastinal disorders8/1378/136
FatigueGeneral disorders7/1377/136
PyrexiaGeneral disorders4/1377/136
ArthralgiaMusculoskeletal and connective tissue disorders7/1377/136
DepressionPsychiatric disorders4/1377/136
HypercholesterolaemiaMetabolism and nutrition disorders7/1370/136

Baseline characteristics

Baseline characteristics were analyzed for all participants who were treated.

Age, Continuous
Age, Continuous(years)DRV/Rtv MONODRV/Rtv + 2NRTIsTotal
Mean44.6 ± 11.2143.1 ± 10.4143.9 ± 10.82
Sex: Female, Male
Sex: Female, Male(Participants)DRV/Rtv MONODRV/Rtv + 2NRTIsTotal
Female262147
Male111115226
Region of Enrollment
Region of Enrollment(participants)DRV/Rtv MONODRV/Rtv + 2NRTIsTotal
AUSTRIA5510
BELGIUM7815
DENMARK8715
FRANCE161228
GERMANY111122
HUNGARY538
IRELAND358
ISRAEL5510
ITALY222446
POLAND7613
SPAIN172340
SWEDEN347
SWITZERLAND10515
UNITED KINGDOM181836
08

Study locations

36 sites
  • Graz, Austria
  • Wien, Austria
  • Antwerpen, Belgium
  • Brussels, Belgium
  • Bruxelles, Belgium
  • Gent, Belgium
  • Copenhagen, Denmark
  • Hvidovre N/A, Denmark
  • Bobigny, France
  • Bondy Cedex, France
  • Dijon, France
  • Paris Cedex 12, France
  • Paris, France
  • Berlin, Germany
  • Bonn, Germany
  • Frankfurt, Germany
  • Hannover, Germany
  • Köln, Germany
  • Budapest, Hungary
  • Dublin 9, Ireland
  • Galway, Ireland
  • Beer Sheva, Israel
  • Ramat-Gan, Israel
  • Tel-Aviv, Israel
  • Warszawa, Poland
  • Badalona, Spain
  • Barcelona, Spain
  • Cordoba, Spain
  • Granada, Spain
  • Madrid, Spain
  • Stockholm, Sweden
  • St Gallen, Switzerland
  • Zurich, Switzerland
  • Brighton, United Kingdom
  • London, United Kingdom
  • Manchester, United Kingdom
09

References and documents

Publications

  • Girard PM, Antinori A, Arribas JR, Ripamonti D, Bicer C, Netzle-Sveine B, Hadacek B, Moecklinghoff C. Week 96 efficacy and safety of darunavir/ritonavir monotherapy vs. darunavir/ritonavir with two nucleoside reverse transcriptase inhibitors in the PROTEA trial. HIV Med. 2017 Jan;18(1):5-12. doi: 10.1111/hiv.12386. Epub 2016 Jun 9. PubMed 27279571 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01448707
Lead sponsor
Janssen-Cilag International NV
Responsible party
Sponsor
First posted
Oct 7, 2011
Start date
Mar 15, 2012
Primary completion
Jun 11, 2014
Completion
Mar 18, 2015
Results posted
Dec 3, 2015
Last update
Nov 27, 2017

Study contacts

Janssen-Cilag International NV Clinical Trial
study director · Janssen-Cilag International NV

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Acquired Immunodeficiency Syndrome→

Other studies from this sponsor

Janssen-Cilag International NV

Start the discussion