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To assess the viral load response, safety, tolerability and pharmacokinetics of multiple oral doses of PF 00232798 in HIV-positive patient volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-00232798 40 mg | Active Comparator |
| |
| PF-00232798 300 mg | Active Comparator |
| |
| PF-00232798 400 mg | Active Comparator |
| |
| PF-00232798 5 mg | Active Comparator |
| |
| PF-00232798 20 mg | Active Comparator |
| |
| PF-00232798 150 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-00232798 | Drug | Solution, 20 mg. once daily, 10 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11 | Viral load was determined using the Roche COBAS Taqman HIV-1 assay with a lower limit of detection of 40 copies per milliliter (copies/mL). Samples with an initial reading of less than 1,000,000 copies/mL were diluted into range and re-assayed. | Baseline, Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load | The time to rebound of viral load was calculated as the time from the last dose to the time of the first occasion at which the viral load was greater than the baseline value. Results are reported for number of participants who rebound within specified days from last dose and who did not rebound up to Day 25. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Viral Tropism and Resistance | Virus tropism was determined using the Monogram PhenoSense Entry assay; standard Trofile tropisim assay was used for Stage 1 and enhanced sensitivity Trofile tropisim assay was used for Stage 2. | Screening, pre-dose on Day 1; Day 11, 25 |
| Number of Participants With Chemokine Receptor 5 (CCR5) Delta 32 Genotyping and Immunophenotyping |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Cologne | 50937 | Germany | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. |
| FG001 | PF-00232798 5 mg | Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. |
| FG002 | PF-00232798 20 mg | Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. |
| FG003 | PF-00232798 150 mg | Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. |
| FG004 | PF-00232798 40 mg | Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. |
| FG005 | PF-00232798 300 mg | Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. |
| FG006 | PF-00232798 400 mg | Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 (25 Days) |
|
| ||||||||||||||||||
| Stage 2 (25 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-00232798 5 mg | Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. |
| BG001 | PF-00232798 20 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11 | Viral load was determined using the Roche COBAS Taqman HIV-1 assay with a lower limit of detection of 40 copies per milliliter (copies/mL). Samples with an initial reading of less than 1,000,000 copies/mL were diluted into range and re-assayed. | Pharmacodynamic population included all participants who were randomized, treated and had at least 1 post-dose HIV viral load measurement in the study. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline, Day 11 |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-00232798 5 mg | Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| C530956 | PF 232798 |
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| PF-00232798 |
| Drug |
Solution, 150 mg. once daily, 10 days |
|
| PF-00232798 | Drug | Solution, 5 mg. once daily, 10 days |
|
| PF-00232798 | Drug | Solution, 40 mg. once daily, 10 days |
|
| PF-00232798 | Drug | Solution, 300 mg. once daily, 10 days |
|
| PF-00232798 | Drug | Solution, 400 mg. once daily, 10 days |
|
| Day 1 up to Day 25 |
| Maximum Observed Plasma Concentration (Cmax) | 0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | AUCtau= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time end of dosing interval (24 hours post-dose). | 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10 |
CCR5 Delta 32 genotyping and immunophenotyping was to be done to assess CCR5 Delta 32 status, other CCR5 polymorphisms, enzymes involved in drug metabolism and/or drug transport proteins in order to measure the impact of genetic variation with respect to PF-00232798 in case any unusual patterns of response or an unexplained excess of adverse events occurred. |
| Pre-dose on Day 1 |
| Frankfurt am Main |
| 60590 |
| Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
| BG002 | PF-00232798 40 mg | Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. |
| BG003 | PF-00232798 150 mg | Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. |
| BG004 | PF-00232798 300 mg | Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. |
| BG005 | PF-00232798 400mg | Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. |
| BG006 | Placebo | Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. |
| OG002 | PF-00232798 40 mg | Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. |
| OG003 | PF-00232798 150 mg | Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. |
| OG004 | PF-00232798 300 mg | Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. |
| OG005 | PF-00232798 400 mg | Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. |
| OG006 | Placebo | Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. |
|
|
| Secondary | Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load | The time to rebound of viral load was calculated as the time from the last dose to the time of the first occasion at which the viral load was greater than the baseline value. Results are reported for number of participants who rebound within specified days from last dose and who did not rebound up to Day 25. | Pharmacodynamic population included all participants who were randomized, treated and had at least 1 post-dose HIV viral load measurement in the study. | Posted | Number | participants | Day 1 up to Day 25 |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study. | Posted | Geometric Mean | Standard Deviation | nanogram per milliliter (ng/mL) | 0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study. | Posted | Median | Full Range | hours | 0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning |
|
|
|
| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | AUCtau= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time end of dosing interval (24 hours post-dose). | Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study. | Posted | Geometric Mean | Standard Deviation | nanogram*hour per milliliter (ng*hr/mL) | 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10 |
|
|
|
| Other Pre-specified | Number of Participants With Viral Tropism and Resistance | Virus tropism was determined using the Monogram PhenoSense Entry assay; standard Trofile tropisim assay was used for Stage 1 and enhanced sensitivity Trofile tropisim assay was used for Stage 2. | Results for this outcome was not reported because data was collected in individual participant listings, but not summarized for analyses. | Posted | Screening, pre-dose on Day 1; Day 11, 25 |
|
|
| Other Pre-specified | Number of Participants With Chemokine Receptor 5 (CCR5) Delta 32 Genotyping and Immunophenotyping | CCR5 Delta 32 genotyping and immunophenotyping was to be done to assess CCR5 Delta 32 status, other CCR5 polymorphisms, enzymes involved in drug metabolism and/or drug transport proteins in order to measure the impact of genetic variation with respect to PF-00232798 in case any unusual patterns of response or an unexplained excess of adverse events occurred. | Results for this outcome were not analyzed because there were no unusual patterns of response or an unexplained excess of adverse events that warranted genotyping. | Posted | Pre-dose on Day 1 |
|
|
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | PF-00232798 20 mg | Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. | 1 | 6 | 6 | 6 |
| EG002 | PF-00232798 40 mg | Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. | 0 | 8 | 7 | 8 |
| EG003 | PF-00232798 150 mg | Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. | 0 | 6 | 5 | 6 |
| EG004 | PF-00232798 300 mg | Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. | 0 | 8 | 6 | 8 |
| EG005 | PF-00232798 400mg | Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. | 1 | 7 | 3 | 7 |
| EG006 | Placebo | Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. | 0 | 2 | 2 | 2 |
| Angiopathy | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Panophthalmitis | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Gastric disorder | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hunger | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Lymphangitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Transaminases abnormal | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Rebound within 3 days |
|
| Rebound within 5 days |
|
| Rebound within 9 days |
|
| Rebound within 12 days |
|
| Rebound within 15 days |
|
| No Rebound |
|