Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U01CA121947 | U.S. NIH Grant/Contract | View source | |
| CDR0000593634 | Other Identifier | NCI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| The Emmes Company, LLC | INDUSTRY |
Not provided
Not provided
Not provided
RATIONALE: Vaccines made from virus proteins may help the body build an effective immune response to prevent cervical cancer.
PURPOSE: This pilot study is looking at the side effects of a human papillomavirus vaccine and how well it works in preventing cervical cancer in women in India with HIV-1 infection.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive quadrivalent human papillomavirus (HPV) (types 6, 11, 16, 18) recombinant vaccine intramuscularly on day 0 and once in weeks 8 and 24.
Patients undergo cervical cell, buccal cell, and blood sample collection at baseline and periodically after vaccination for immunologic and virologic studies. Cervical cytology specimens are examined by polymerase chain reaction to detect HPV 6, 11, 16, or 18 DNA, as well as 35 other HPV types. Blood samples are analyzed for CD4+/CD8+ cell count, plasma HIV-1 RNA levels, and serum HPV antibody titers for HPV types 6, 11, 16, and 18. Some plasma samples will be stored for future HPV pseudovirion neutralization assays.
After completion of study therapy, patients are followed periodically for up to 12 months.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gardasil Vaccination | Experimental | Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine | Biological | Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0 | Number of grade 3 or 4 adverse events attributed to vaccine per 100 patients | 52 weeks from study entry |
| Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count | Significant decrease (at the 0.05 significance level) in CD4+ cell count to 75% of the baseline level on two or more consecutive tests | Screening/Week 0, Weeks 2, 10, 26, and 52. |
| Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28 | Number of participants with detectable HPV antibody to HPV 16 among those with undetectable antibodies to HPV 16 at baseline | Week 28 |
| Number of Patients With a Significant Increase in HIV Viral Load | Number of patients with a significant increase in HIV viral load defined as > 1 log increase in HIV load from baseline on 2 consecutive occasions | Screening/week 0, weeks, 2, 10, 26 and 52 |
| Number of Patients With Detectable Antibodies to HPV-6 | Detectable antibodies to HPV-6 among participant who had undetectable antibodies to HPV-6 at baseline | 28 weeks |
| Number of Patients With Detectable Antibodies to HPV-11 | Detectable antibodies to HPV-11 among those who had undetectable antibodies to HPV-11 at baseline | 28 weeks |
| Number of Patients With Detectable Antibodies to HPV-18 |
Not provided
Not provided
DISEASE CHARACTERISTICS:
HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by western blot before study entry
Meets 1 of the following criteria:
No known history of high-grade CIN or cervical cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
More than 45 days since prior systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joel Palefsky, MD | University of California, San Francisco | Study Chair |
| N. Kumarasamy, MD | YRG Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| YRG Care | Chennai | 600113 | India |
Not provided
| Label | URL |
|---|---|
| Clinical trial summary for AMC-054 | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Gardasil Vaccination | Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. DNA analysis: Weeks 0, 2, 10, 26, and 52. polymerase chain reaction: Screening, week 36, and week 52. cytology specimen collection procedure: Screening, week 36, and week 52. colposcopic biopsy: Screening, week 36, and week 52. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| DNA analysis | Genetic | Weeks 0, 2, 10, 26, and 52. |
|
|
| polymerase chain reaction | Genetic | Screening, week 36, and week 52. |
|
| cytology specimen collection procedure | Other | Screening, week 36, and week 52. |
|
| colposcopic biopsy | Procedure | Screening, week 36, and week 52. |
|
Detectable antibodies to HPV-18 among participants with undetectable antibodies to HPV-18 at baseline |
| 28 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Enrolled in study
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gardasil Vaccination | Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. DNA analysis: Weeks 0, 2, 10, 26, and 52. polymerase chain reaction: Screening, week 36, and week 52. cytology specimen collection procedure: Screening, week 36, and week 52. colposcopic biopsy: Screening, week 36, and week 52. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0 | Number of grade 3 or 4 adverse events attributed to vaccine per 100 patients | Intent-to-treat | Posted | Number | 95% Confidence Interval | Grade 3/4 adverse events per 100 patient | 52 weeks from study entry |
|
|
| |||||||||||||||||||||||||
| Primary | Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count | Significant decrease (at the 0.05 significance level) in CD4+ cell count to 75% of the baseline level on two or more consecutive tests | Intent-to-treat | Posted | Number | participants | Screening/Week 0, Weeks 2, 10, 26, and 52. |
|
| |||||||||||||||||||||||||||
| Primary | Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28 | Number of participants with detectable HPV antibody to HPV 16 among those with undetectable antibodies to HPV 16 at baseline | Per-protocol population with undetectable HPV-16 levels at baseline | Posted | Number | participants | Week 28 |
|
| |||||||||||||||||||||||||||
| Primary | Number of Patients With a Significant Increase in HIV Viral Load | Number of patients with a significant increase in HIV viral load defined as > 1 log increase in HIV load from baseline on 2 consecutive occasions | Posted | Number | participants | Screening/week 0, weeks, 2, 10, 26 and 52 |
|
| ||||||||||||||||||||||||||||
| Primary | Number of Patients With Detectable Antibodies to HPV-6 | Detectable antibodies to HPV-6 among participant who had undetectable antibodies to HPV-6 at baseline | Per-protocol participants with undetectable antibodies to HPV-6 at baseline | Posted | Number | participants | 28 weeks |
|
| |||||||||||||||||||||||||||
| Primary | Number of Patients With Detectable Antibodies to HPV-11 | Detectable antibodies to HPV-11 among those who had undetectable antibodies to HPV-11 at baseline | Per-protocol population of participants with undetectable antibodies for HPV-11 at baseline | Posted | Number | participants | 28 weeks |
|
| |||||||||||||||||||||||||||
| Primary | Number of Patients With Detectable Antibodies to HPV-18 | Detectable antibodies to HPV-18 among participants with undetectable antibodies to HPV-18 at baseline | Per-protocol population of participants with undetectable HPV-18 antibodies at baseline | Posted | Number | participants | 28 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gardasil Vaccination | Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. DNA analysis: Weeks 0, 2, 10, 26, and 52. polymerase chain reaction: Screening, week 36, and week 52. cytology specimen collection procedure: Screening, week 36, and week 52. colposcopic biopsy: Screening, week 36, and week 52. | 4 | 150 | 145 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Meningitis | Infections and infestations | Non-systematic Assessment |
| ||
| Lung Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Leptospirosis | Infections and infestations | Non-systematic Assessment |
| ||
| Seizure | Nervous system disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Lung Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Skin Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Upper Respiratory Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Vaginal Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Vulval Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Vaginal Discharge | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Cough | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash, maculo-papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeannette Y. Lee | AMC | 5015266712 | jylee@uams.edu |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D011230 | Precancerous Conditions |
| D030361 | Papillomavirus Infections |
| D002578 | Uterine Cervical Dysplasia |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086982 | Blood-Borne Infections |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| D016133 | Polymerase Chain Reaction |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D053918 | Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
Not provided
Not provided
|
|
|
|
|
|