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TerminatedNCT00823979Updated Dec 4, 2018Results posted

A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1

A Phase 2 interventional study of UK-453,061 Dose 1 and UK-453,061 Dose 2 in HIV-1, sponsored by Pfizer. Terminated at 63 sites in 13 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-12-04.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Why this study was terminated
See termination reason in detailed description.
Phase
Phase 2
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a 96 week study to determine if UK- 453,061 in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase inhibitor is as efficacious, safe and tolerable as etravirine in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase inhibitor in HIV-1 infected patients who have been previously treated with antiretroviral drugs and have NNRTI resistance mutations.

Read the detailed description

The trial was terminated on 12 April, 2012 due to lack of efficacy at the Week 24 analysis. The decision to terminate the trial was not based on any safety concerns.

02

Conditions studied

  • HIV-1

Keywords

  • HIV-1 NNRTI Treatment Experienced
  • may have Protease inhibitor experience
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.
  • HIV 1 RNA viral load of greater then 500 copies/mL.
  • Negative urine pregnancy test.

Exclusion criteria

Exclusion Criteria:

  • Suspected or documented active, untreated HIV-1 related opportunistic infection or other condition requiring acute therapy at the time of randomization.
  • Subjects with acute Hepatitis B and/or C within 30 days of randomization.
  • Previous use of Darunavir or etravirine
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
105 participants (actual)

Study arms

  • Experimental
    UK- 453,061 Dose One

    Drug: UK-453,061 Dose 1

  • Experimental
    UK- 453,061 Dose Two

    Drug: UK-453,061 Dose 2

  • Active comparator
    Comparator

    Drug: Etravirine

Interventions

  • DrugUK-453,061 Dose 1

    UK 453,061 750 mg QD + one optimized NRTI + darunavir/ritonavir.

  • DrugUK-453,061 Dose 2

    UK 453,061 1000 mg QD + one optimized NRTI + darunavir/ritonavir.

  • DrugEtravirine

    Etravirine 200 mg BID + one optimized NRTI + darunavir/ritonavir.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/Milliliter (mL) at Week 24

    Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).

    Time frame: Week 24

Secondary outcomes

  1. Percentage of Participants With HIV-1 RNA Levels <50 Copies/mL at Week 48 and 96

    Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).

    Time frame: Weeks 48, 96

  2. Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Week 24, 48 and 96

    Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).

    Time frame: Week 24, 48, 96

  3. Change From Baseline in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96

    Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5). For the log10 scale, all the HIV-1 RNA levels were log10 transformed prior to the average calculations. Baseline value calculated as average of measurements collected prior to and including Day 1 pre-dose.

    Time frame: Baseline, Week 24, 48, 96

  4. Time-Averaged Difference (TAD) in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96

    TAD was calculated as (area under the curve of HIV-1 RNA levels \[log10 copies/mL\] from baseline to the time point of interest divided by time period in weeks) minus baseline HIV-1 RNA level (log10 copies/mL). Baseline value calculated as average of measurements collected at prior to and including Day 1 pre-dose. Due to early termination of the study decision was made not to derive TAD results for Week 96.

    Time frame: Week 24, 48, 96

  5. Percentage of Participants With Response as Determined by the Time to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96

    TLOVR50 response (50 denotes lower limit of quantification \[LLOQ\] of assay=50 copies/mL): compliment to TLOVR50 failure. TLOVR50 failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of drug; lost to follow-up; new ARV drug; met treatment failure \[TF\] criteria). TF: an increase of at least (\>=)3 times the baseline plasma HIV-1 RNA level at Week 2 or thereafter; failure to achieve HIV-1 RNA level \<50 copies/mL at Week 24; starting at Week 2, an increase in HIV-1 RNA level to detectable levels (\>50 copies/mL); HIV-1 RNA \<1 log10 decrease from baseline at Week 4 or thereafter. TF were confirmed by second measurement \>=14 days after first. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.

    Time frame: Week 24, 48, 96

  6. Change From Baseline in Cluster of Differentiation 4 (CD4+) Absolute Lymphocyte Counts at Week 24, 48 and 96

    Blood samples for immunological status assessed by CD4+ lymphocyte count. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.

    Time frame: Baseline, Week 24, 48, 96

  7. Change From Baseline in Cluster of Differentiation 4 (CD4+) Percentage Lymphocyte Counts at Week 24, 48, 96

    Blood samples for immunological status assessed by CD4+ lymphocyte count. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.

    Time frame: Baseline, Week 24, 48, 96

  8. Number of Participants With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Resistance-Associated Mutations (RAMs) and/or Phenotypic Susceptibility at Time of Treatment Failure Through Week 48

    Genotypic and phenotypic resistance to NNRTIs based on International Acquired Immunodeficiency Syndrome (AIDS) Society, United States of America (IAS-USA) RAM guidelines were evaluated using Monogram Biosciences PhenoSenseGT Assay at Baseline. This was then repeated for all participants with HIV-1 viral load \>500 copies/mL at treatment failure, up to Week 48.

    Time frame: Baseline through Week 48

  9. Number of Participants With Laboratory Test Abnormalities

    Laboratory analysis included blood chemistry, hematology and urinalysis.

    Time frame: Baseline up to Week 48 or early termination

  10. Population Pharmacokinetics (PK) of Lersivirine

    Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

    Time frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48

  11. Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)

    Simple quartile exposure analysis of success rate (viral load \<50 copies/mL) versus median Cmin assesses the exposure response relationship. Percentage of participants with HIV-1 RNA level \<50 copies/mL at median Cmin quartile were planned to be reported.

    Time frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48

07

Results

Posted Mar 14, 2014
Limitations and caveats
The trial was terminated on 12 April, 2012 due to lack of efficacy at the Week 24 analysis. The decision to terminate the trial was not based on any safety concerns.

Participant flow

Participant flow — Overall Study
MilestoneLersivirine 750 mgLersivirine 1000 mgEtravirine 200 mg
Started353535
Treated313234
Completed6311
Not completed293224
Withdrew: Lack of efficacy13169
Withdrew: Lost to follow-up210
Withdrew: Withdrawal by subject232
Withdrew: Protocol violation110
Withdrew: Pregnancy010
Withdrew: Adverse event024
Withdrew: Other201
Withdrew: Randomized but not treated431
Withdrew: Study terminated by sponsor557

Outcome measures

PrimaryPercentage of Participants With Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/Milliliter (mL) at Week 24

Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).

Time frame:
Week 24
Reported as:
Number · percentage of participants
Percentage of Participants With Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/Milliliter (mL) at Week 24
percentage of participantsLersivirine 750 mgLersivirine 1000 mgEtravirine 200 mg
Percentage of Participants With Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/Milliliter (mL) at Week 2448.443.867.6
SecondaryPercentage of Participants With HIV-1 RNA Levels <50 Copies/mL at Week 48 and 96

Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).

Time frame:
Weeks 48, 96
Reported as:
Number · percentage of participants
Percentage of Participants With HIV-1 RNA Levels <50 Copies/mL at Week 48 and 96
percentage of participantsLersivirine 750 mgLersivirine 1000 mgEtravirine 200 mg
Week 48 (n=31, 32, 34)41.931.361.8
Week 96 (n=28, 28, 27)25.014.337.0
SecondaryPercentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Week 24, 48 and 96

Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).

Time frame:
Week 24, 48, 96
Reported as:
Number · percentage of participants
Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Week 24, 48 and 96
percentage of participantsLersivirine 750 mgLersivirine 1000 mgEtravirine 200 mg
Week 24 (n=31, 32, 34)54.850.079.4
Week 48 (n=31, 32, 34)41.934.470.6
Week 96 (n=28, 28, 27)25.014.337.0
SecondaryChange From Baseline in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96

Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5). For the log10 scale, all the HIV-1 RNA levels were log10 transformed prior to the average calculations. Baseline value calculated as average of measurements collected prior to and including Day 1 pre-dose.

Time frame:
Baseline, Week 24, 48, 96
Reported as:
Mean · log10 copies/mL
Change From Baseline in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96
log10 copies/mLLersivirine 750 mgLersivirine 1000 mgEtravirine 200 mg
Baseline4.28 ± 0.994.76 ± 0.824.59 ± 0.79
Change at Week 24-1.53 ± 1.58-1.89 ± 1.46-2.32 ± 1.21
Change at Week 48-1.30 ± 1.64-1.08 ± 1.48-2.06 ± 1.42
Change at Week 96-0.69 ± 1.39-0.36 ± 1.00-0.96 ± 1.49
SecondaryTime-Averaged Difference (TAD) in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96

TAD was calculated as (area under the curve of HIV-1 RNA levels \[log10 copies/mL\] from baseline to the time point of interest divided by time period in weeks) minus baseline HIV-1 RNA level (log10 copies/mL). Baseline value calculated as average of measurements collected at prior to and including Day 1 pre-dose. Due to early termination of the study decision was made not to derive TAD results for Week 96.

Time frame:
Week 24, 48, 96
Reported as:
Mean · log10 copies/mL
Time-Averaged Difference (TAD) in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96
log10 copies/mLLersivirine 750 mgLersivirine 1000 mgEtravirine 200 mg
Week 24-1.46 ± 1.12-1.72 ± 1.11-2.10 ± 0.92
Week 48-1.28 ± 1.39-1.19 ± 1.35-1.89 ± 1.27
SecondaryPercentage of Participants With Response as Determined by the Time to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96

TLOVR50 response (50 denotes lower limit of quantification \[LLOQ\] of assay=50 copies/mL): compliment to TLOVR50 failure. TLOVR50 failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of drug; lost to follow-up; new ARV drug; met treatment failure \[TF\] criteria). TF: an increase of at least (\>=)3 times the baseline plasma HIV-1 RNA level at Week 2 or thereafter; failure to achieve HIV-1 RNA level \<50 copies/mL at Week 24; starting at Week 2, an increase in HIV-1 RNA level to detectable levels (\>50 copies/mL); HIV-1 RNA \<1 log10 decrease from baseline at Week 4 or thereafter. TF were confirmed by second measurement \>=14 days after first. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.

Time frame:
Week 24, 48, 96
Reported as:
Number · percentage of participants
Percentage of Participants With Response as Determined by the Time to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96
percentage of participantsLersivirine 750 mgLersivirine 1000 mgEtravirine 200 mg
Week 2448.443.867.6
Week 4841.928.155.9
SecondaryChange From Baseline in Cluster of Differentiation 4 (CD4+) Absolute Lymphocyte Counts at Week 24, 48 and 96

Blood samples for immunological status assessed by CD4+ lymphocyte count. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.

Time frame:
Baseline, Week 24, 48, 96
Reported as:
Mean · cells per microliter (cells/mcL)
Change From Baseline in Cluster of Differentiation 4 (CD4+) Absolute Lymphocyte Counts at Week 24, 48 and 96
cells per microliter (cells/mcL)Lersivirine 750 mgLersivirine 1000 mgEtravirine 200 mg
Baseline247 ± 143259 ± 187227 ± 146
Change at Week 2498 ± 14066 ± 111110 ± 108
Change at Week 48122 ± 14874 ± 128128 ± 127
Change at Week 96148 ± 17789 ± 152184 ± 197
SecondaryChange From Baseline in Cluster of Differentiation 4 (CD4+) Percentage Lymphocyte Counts at Week 24, 48, 96

Blood samples for immunological status assessed by CD4+ lymphocyte count. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.

Time frame:
Baseline, Week 24, 48, 96
Reported as:
Mean · percentage of total lymphocytes
Change From Baseline in Cluster of Differentiation 4 (CD4+) Percentage Lymphocyte Counts at Week 24, 48, 96
percentage of total lymphocytesLersivirine 750 mgLersivirine 1000 mgEtravirine 200 mg
Baseline16.1 ± 8.715.0 ± 8.814.6 ± 8.3
Change at Week 243.0 ± 4.03.7 ± 3.63.7 ± 3.2
Change at Week 484.6 ± 5.34.0 ± 4.14.4 ± 3.8
Change at Week 965.4 ± 6.14.2 ± 4.96.2 ± 6.2
SecondaryNumber of Participants With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Resistance-Associated Mutations (RAMs) and/or Phenotypic Susceptibility at Time of Treatment Failure Through Week 48

Genotypic and phenotypic resistance to NNRTIs based on International Acquired Immunodeficiency Syndrome (AIDS) Society, United States of America (IAS-USA) RAM guidelines were evaluated using Monogram Biosciences PhenoSenseGT Assay at Baseline. This was then repeated for all participants with HIV-1 viral load \>500 copies/mL at treatment failure, up to Week 48.

Time frame:
Baseline through Week 48
Reported as:
Number · participants
Number of Participants With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Resistance-Associated Mutations (RAMs) and/or Phenotypic Susceptibility at Time of Treatment Failure Through Week 48
participantsLersivirine 750 mgLersivirine 1000 mgEtravirine 200 mg
Number of Participants With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Resistance-Associated Mutations (RAMs) and/or Phenotypic Susceptibility at Time of Treatment Failure Through Week 48531
SecondaryNumber of Participants With Laboratory Test Abnormalities

Laboratory analysis included blood chemistry, hematology and urinalysis.

Time frame:
Baseline up to Week 48 or early termination
Reported as:
Number · participants
Number of Participants With Laboratory Test Abnormalities
participantsLersivirine 750 mgLersivirine 1000 mgEtravirine 200 mg
Number of Participants With Laboratory Test Abnormalities273033
SecondaryPopulation Pharmacokinetics (PK) of Lersivirine

Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

Time frame:
Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48

Results for this outcome have not been posted.

SecondaryLersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)

Simple quartile exposure analysis of success rate (viral load \<50 copies/mL) versus median Cmin assesses the exposure response relationship. Percentage of participants with HIV-1 RNA level \<50 copies/mL at median Cmin quartile were planned to be reported.

Time frame:
Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lersivirine 750 mg—1/31 (3.2%)27/31 (87.1%)
Lersivirine 1000 mg—4/32 (12.5%)25/32 (78.1%)
Etravirine 200 mg—1/34 (2.9%)32/34 (94.1%)
Most frequent serious events
Most frequent serious events
EventLersivirine 750 mgLersivirine 1000 mgEtravirine 200 mg
Pulmonary tuberculosisInfections and infestations0/312/320/34
HypertensionVascular disorders1/310/320/34
Coronary artery diseaseCardiac disorders0/311/320/34
Head injuryInjury, poisoning and procedural complications0/311/320/34
Pneumocystis jiroveci pneumoniaInfections and infestations0/310/321/34
PneumoniaInfections and infestations0/310/321/34
Most frequent other events
Showing 10 of 191
Most frequent other events
EventLersivirine 750 mgLersivirine 1000 mgEtravirine 200 mg
NauseaGastrointestinal disorders8/3114/324/34
DiarrhoeaGastrointestinal disorders8/317/326/34
VomitingGastrointestinal disorders6/313/323/34
Herpes zosterInfections and infestations0/310/325/34
Upper respiratory tract infectionInfections and infestations3/313/325/34
Back painMusculoskeletal and connective tissue disorders2/310/325/34
RashSkin and subcutaneous tissue disorders0/310/325/34
InfluenzaInfections and infestations4/310/324/34
HeadacheNervous system disorders2/312/324/34
Abdominal pain upperGastrointestinal disorders1/313/323/34

Baseline characteristics

Intent-to-Treat (ITT) population included all randomized participants who received at least 1 dose of study drug.

Age, Continuous
Age, Continuous(years)Lersivirine 750 mgLersivirine 1000 mgEtravirine 200 mgTotal
Mean41.1 ± 8.940.0 ± 8.741.9 ± 9.141.0 ± 8.9
Sex: Female, Male
Sex: Female, Male(Participants)Lersivirine 750 mgLersivirine 1000 mgEtravirine 200 mgTotal
Female15181851
Male16141646
08

Study locations

63 sites
  • Jeffrey Goodman Special Care Clinic
    Los Angeles, California 90028, United States
  • Office of Anthony Mills, MD, Inc.
    Los Angeles, California 90069, United States
  • CARES
    Sacramento, California 95814, United States
  • University of California Davis Medical Center
    Sacramento, California 95817, United States
  • San Francisco Veterans Affairs Medical Center
    San Francisco, California 94121, United States
  • The Kinder Medical Group
    Miami, Florida 33133, United States
  • Care Resource
    Miami, Florida 33137, United States
  • Orlando Immunology Center
    Orlando, Florida 32803, United States
  • Infectious Diseases Associates of Northwest Florida, PA
    Pensacola, Florida 32504, United States
  • Hillsborough County Health Department
    Tampa, Florida 33602, United States
  • AIDS Research Consortium of Atlanta
    Atlanta, Georgia 30308, United States
  • Ruth M. Rothstein CORE Center
    Chicago, Illinois 60612, United States
  • Nassau University Medical Center
    East Meadow, New York 11554, United States
  • Greiger Clinic
    Mount Vernon, New York 10550, United States
  • Rosedale Infectious Diseases
    Huntersville, North Carolina 28078, United States
  • University of Cincinnati Medical Center
    Cincinnati, Ohio 45267-0405, United States
  • Saint Hope Foundation - Bellaire Clinic
    Bellaire, Texas 77401, United States
  • Saint Hope Foundation - Conroe Clinic
    Conroe, Texas 77301, United States
  • Nicholaos C. Bellos, MD, PA
    Dallas, Texas 75204, United States
  • University of Texas Southwestern Medical Center at Dallas
    Dallas, Texas 75235, United States
  • Saint Hope Foundation - Stafford Clinic
    Stafford, Texas 77477, United States
  • Instituto A.Z. de Pesquisa e Ensino
    Curitiba, Paraná 80240-280, Brazil
  • Hospital Geral de Nova Iguacu
    Nova Iguaçu, Rio de Janeiro 26030-381, Brazil
  • Hospital Nossa Senhora da Conceicao
    Porto Alegre, Rio Grande do Sul 91350-200, Brazil
  • Instituto de Infectologia Campinas
    Campinas, São Paulo 13015-080, Brazil
  • Centro de Referencia e Treinamento DST/AIDS
    São Paulo, São Paulo 04121-000, Brazil
  • Hospital Heliopolis
    São Paulo, São Paulo 04231-030, Brazil
  • Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin
    Cologne, 50937, Germany
  • Unita' Operativa Malattie Infettive
    Bologna, 40138, Italy
  • U.O.S. Immunologia Clinica
    Roma, 00184, Italy
  • Hospital Raja Perempuan Zainab II
    Kota Bharu, Kelantan 15586, Malaysia
  • University Malaya Medical Centre
    Kuala Lumpur, 59100, Malaysia
  • Oddzial do Leczenia HIV
    Szczecin, 71-455, Poland
  • SPZOZ Wojewodzki Szpital Zakazny
    Warsaw, 01-201, Poland
  • Hospitais da Universidade de Coimbra
    Coimbra, 3000-075, Portugal
  • Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos
    Lisbon, 1169-050, Portugal
  • Centro Hospitalar de Lisboa Ocidental, EPE.
    Lisbon, 1349-019, Portugal
  • Hospital São João
    Porto, 4200-319, Portugal
  • Hospital de Joaquim Urbano
    Porto, 4369-004, Portugal
  • UPR-CTU Pharmacy
    San Juan, PR 00935, Puerto Rico
  • Innovative Care PSC
    Bayamón, 00959, Puerto Rico
  • Ararat Research Center
    Ponce, 00717-1563, Puerto Rico
  • University of Puerto Rico - Medical Sciences Campus - Puerto Rico Medical Center
    Rio Piedras, 00935, Puerto Rico
  • HOPE Clinical Research
    San Juan, 00909, Puerto Rico
  • Soweto Clinical Trials Centre
    Johannesburg, Gauteng 1818, South Africa
  • University of Witwatersrand
    Johannesburg, Gauteng 2193, South Africa
  • Chris Hani Baragwanath Hospital
    Soweto, Johannesburg 2013, South Africa
  • Dr. J Fourie Medical Centre
    Dundee, KwaZulu-Natal 3000, South Africa
  • 203 Maxwell Centre
    Durban, KwaZulu-Natal 4001, South Africa
  • Willowmead Medical Center
    Cape Town, Western Cape 7780, South Africa
  • Desmond Tutu HIV Foundation
    Cape Town, Western Cape 7925, South Africa
  • Hospital Universitari Germans Trias I Pujol
    Badalona, Barcelona 08916, Spain
  • Hospital Universitario La Paz
    Madrid, 28046, Spain
  • Department of Infectious Disease, E-Da Hospital
    Kaohsiung County, 82445, Taiwan
  • Veterans General Hospital - Taipei
    Taipei, Taiwan
  • Vinnitsa Regional center for AIDS Prevention and Control
    Berezyna, Vinnitsa District, Vinnitsa Region 23222, Ukraine
  • Donetsk Regional Center of AIDSs prophylaxis and control
    Donetsk, 83045, Ukraine
  • Lugansk Regional Center of AIDS prophylaxis and control
    Luhansk, 91045, Ukraine
  • Brighton and Sussex University Hospitals NHS Trust
    Brighton, EAST Sussex BN2 1ES, United Kingdom
  • North Manchester General Hospital
    Crumpsall, Greater Manchester M8 5RB, United Kingdom
  • Royal Infirmary GUM Clinic
    Edinburgh, EH3 9HA, United Kingdom
  • Western General Hospital
    Edinburgh, EH4 2XU, United Kingdom
  • Royal Free Hospital
    London, NW3 2QG, United Kingdom
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2009 to primary completion in Oct 2012, 42 months.

Results were first posted in Mar 2014, 1 year 4 months after primary completion. A results delay was requested in Nov 2013.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2009
First posted
Jan 16, 2009
StartActual
Mar 25, 2009
Primary completionActual
Oct 18, 2012
CompletionActual
Oct 18, 2012
Results delay requested
Nov 19, 2013
Results first posted
Mar 14, 2014
Last update
Dec 4, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00823979
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Jan 16, 2009
Start date
Mar 25, 2009
Primary completion
Oct 18, 2012
Completion
Oct 18, 2012
Results posted
Mar 14, 2014
Last update
Dec 4, 2018

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

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

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