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Human Immunodeficiency VirusPhase 1NCT00798265

A Phase I Study of Quadrivalent Human Papilloma Virus (HPV) (Types 6, 11, 16, 18) Recombinant Vaccine in HIV-Infected and HIV-Negative Pre-Adolescents, Adolescents, and Young Adults

A Phase 1 study testing Gardasil and Survey in people with Human Immunodeficiency Virus and Human Papillomavirus- 6, 11, 16, 18, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Background: Human papilloma virus (HPV) is a common sexually transmitted disease. There are more than 100 different HPV types, and both males and females can get HPV infection. Most people do not have any symptoms when they become infected and are able to get rid of the infection on their own. Read more about this study

Who is it for?
Ages 12 to 26 years
What is being tested?
Gardasil and Survey
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
29 Jun 2009to 4 Feb 2013
Phase
Phase 1
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 12 to 26 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 2.1.1.1 Age 12 to 26 years
  • 2.1.1.2 Females and males
  • 2.1.1.3 Human immunodeficiency virus (HIV)-positive
  • 2.1.1.4 Cluster of differentiation 4 (CD4) cell count and Human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) level parameters
  • CD4 cell count greater than or equal to 350 cells/mm(3)
  • HIV-1 RNA level by reverse transcription-polymerase chain reaction (RT PCR) less than or equal to 20,000 copies/ml
Show all 26Show fewer
  • 2.1.1.5 On stable highly active antiretroviral therapy (HAART) regimen for greater than or equal to 6 months with CD4 and viral load parameters as outlined in 2.1.1.4
  • 2.1.1.6 Patients greater than or equal to 18 years willing to provide informed consent or parent/guardian willing to provide informed consent for minor children less than 18 years of age.
  • 2.1.1.7 Informed assent for patients 12-17 years of age (Optional at the discretion of the Principal Investigator and Parent/Guardian based on maturity level of minor)
  • 2.1.1.8 Willing to use acceptable forms of contraception, if applicable, or abstinence to prevent pregnancy.
  • 2.1.2.1 Age 12 to 26 years
  • 2.1.2.2 Females and males
  • 2.1.2.3 HIV-positive
  • 2.1.2.4 CD4 cell count and HIV-1 RNA level parameters
  • CD4 cell count greater than or equal to 500 cells/mm(3)
  • HIV-1 RNA level by RT PCR less than or equal to 20,000 copies/ml.
  • 2.1.2.5 Not receiving antiretroviral treatment with CD4 and viral load parameters as outlined in 2.1.2.4.
  • 2.1.2.6 Patients greater than or equal to 18 years willing to provide informed consent or parent/guardian willing to provide informed consent for minor children less than 18 years of age.
  • 2.1.2.7 Informed assent for patients 12-17 years of age (Optional at the discretion of the Principal Investigator and Parent/Guardian based on maturity level of minor)
  • 2.1.2.8 Willing to use acceptable forms of contraception, if applicable, or abstinence to prevent pregnancy.
  • 2.1.3.1 Age 12 to 26 years
  • 2.1.3.2 Females and males
  • 2.1.3.3 HIV-negative
  • 2.1.3.4 Patients greater than or equal to 18 years willing to provide informed consent or parent/guardian willing to provide informed consent for minor children less than 18 years of age.
  • 2.1.3.5 Informed assent for patients 12-17 years of age (Optional at the discretion of the Principal Investigator and Parent/Guardian based on maturity level of minor)
  • 2.1.3.6 Willing to use acceptable forms of contraception, if applicable, or abstinence to prevent pregnancy.

Who cannot join

  • 2.1.1.9 Any of the following hematologic abnormalities
  • Hemoglobin less than 10.0 g/dL
  • Neutrophil count less than 1500/mm(3)
  • Platelet count less than 75,000/mm(3)
  • Prothrombin time (PT) or partial thromboplastin time (PTT) greater than or equal to 1.5 times upper limits of normal (ULN) (with the exception of patients with known clotting disorders or known lupus anticoagulant).
  • 2.1.1.10 Any of the following hepatic abnormalities
Show all 54Show fewer
  • Alanine transaminase (ALT)/ serum glutamate-pyruvate transaminase (SGPT) and/or Aspartate aminotransferase (AST)/Serum glutamic oxaloacetic transaminase (SGOT) greater than 2.5 times ULN
  • Total bilirubin greater than 1.5 times ULN unless attributable to protease inhibitor therapy.
  • 2.1.1.11 Positive tests (antibody and/or antigen) for hepatitis B and hepatitis C viruses, unless the result is consistent with prior vaccination or prior infection with full recovery.
  • 2.1.1.12 Acute infection requiring therapy at time of enrollment. Participants may be eligible for study after being on stable and appropriate anti-infective therapy.
  • 2.1.1.13 Chemotherapy for active cancer.
  • 2.1.1.14 Documented history of non-adherence to antiretroviral treatment regimen within 12 months of study entry.
  • 2.1.1.15 Pregnancy or breastfeeding.
  • 2.1.1.16 Use of immunosuppressive or immunomodulating agents within 8 weeks of study enrollment. Note: patients receiving oral corticosteroids for management of asthma or contact hypersensitivity for less than or equal to 14 days in duration will be allowed to enroll as long as it has been greater than or equal to 30 days since oral corticosteroid administration.
  • 2.1.1.17 Known immediate hypersensitivity to yeast or any of the vaccine components.
  • 2.1.1.18 Use of investigational agents within 4 weeks prior to study enrollment.
  • 2.1.1.19 Active external genital warts requiring treatment or cervical intraepithelial neoplasia (CIN)2/3
  • 2.1.1.20 Any clinically significant diseases (other than HIV infection) or findings during study screening that, in the opinion of the Principal Investigator or Lead Associate Investigator, may interfere with the study.
  • Cohort 2 Inclusion and Exclusion Eligibility Criteria:
  • 2.1.2.9 Any of the following hematologic abnormalities:
  • Hemoglobin less than 10.0 g/dL
  • Neutrophil count less than 1500/mm(3)
  • Platelet count less than 75,000/mm(3)
  • PT or PTT greater than or equal to 1.5 times ULN (with the exception of patients with known clotting disorders or known lupus anticoagulant).
  • 2.1.2.10 Any of the following hepatic abnormalities
  • ALT/SGPT and/or AST/SGOT greater than 2.5 times ULN
  • Total bilirubin greater than 1.5 times ULN unless attributable to protease inhibitor therapy.
  • 2.1.2.11 Positive tests (antibody and/or antigen) for hepatitis B and hepatitis C viruses, unless the result is consistent with prior vaccination or prior infection with full recovery.
  • 2.1.2.12 Acute infection requiring therapy at time of enrollment. Participants may be eligible for study after being on stable and appropriate anti-infective therapy.
  • 2.1.2.13 Chemotherapy for active cancer.
  • 2.1.2.14 Pregnancy or breastfeeding.
  • 2.1.2.15 Use of immunosuppressive or immunomodulating agents within 8 weeks prior to study enrollment. Note: patients receiving oral corticosteroids for management of asthma or contact hypersensitivity for less than or equal to 14 days in duration will be allowed to enroll as long as it has been greater than or equal to 30 days since oral corticosteroid administration.
  • 2.1.2.16 Known immediate hypersensitivity to yeast or any of the vaccine components.
  • 2.1.2.17 Use of investigational agents within 4 weeks prior to study enrollment.
  • 2.1.2.18 Active external genital warts requiring treatment or CIN2/3
  • 2.1.2.19 Any clinically significant diseases (other than HIV infection) or findings during study screening that, in the opinion of the Principal Investigator or Lead Associate Investigator may interfere with the study.
  • Cohort 3 Inclusion and Exclusion Eligibility Criteria:
  • 2.1.3.7 Any of the following hematologic abnormalities:
  • Hemoglobin less than 10.0 g/dL
  • Neutrophil count less than 1500/mm(3)
  • Platelet count less than 75,000/mm(3)
  • PT or PTT greater than or equal to 1.5 times ULN (with the exception of patients with known clotting disorders or known lupus anticoagulant).
  • 2.1.3.8 Any of the following hepatic abnormalities
  • ALT/SGPT and/or AST/SGOT greater than 2.5 times ULN
  • Total Bilirubin greater than 1.5 times ULN unless attributable to protease inhibitor therapy.
  • 2.1.3.9 Positive tests (antibody and/or antigen) for HIV, hepatitis B and hepatitis C viruses, unless the result is consistent with prior vaccination or prior infection with full recovery.
  • 2.1.3.10 Acute infection requiring therapy at time of enrollment. Participants may be eligible for study after being on stable and appropriate anti-infective therapy.
  • 2.1.3.11 Chemotherapy for active cancer.
  • 2.1.3.12 Pregnancy or breastfeeding
  • 2.1.3.13 Use of immunosuppressive or immunomodulating agents within 8 weeks prior to study enrollment. Note: patients receiving oral corticosteroids for management of asthma or contact hypersensitivity for less than or equal to 14 days in duration will be allowed to enroll as long as it has been greater than or equal to 30 days since oral corticosteroid administration.
  • 2.1.3.14 Known immediate hypersensitivity to yeast or any of the vaccine components.
  • 2.1.3.15 Use of investigational agents within 4 weeks prior to study enrollment.
  • 2.1.3.16 Active external genital warts requiring treatment or carcinoma in-situ 2/3 (CIN2/3)
  • 2.1.3.17 Any clinically significant diseases or findings during study screening that, in the opinion of the Principal Investigator or Lead Associate Investigator may interfere with the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A Phase I Study of Quadrivalent Human Papilloma Virus (HPV) (Types 6, 11, 16, 18) Recombinant Vaccine in HIV-Infected and HIV-Negative Pre-Adolescents, Adolescents and Young Adults

Background:

  • Human papilloma virus (HPV) is a common sexually transmitted disease. There are more than 100 different HPV types, and both males and females can get HPV infection. Most people do not have any symptoms when they become infected and are able to get rid of the infection on their own. However, they can still become re-infected with the same or a different HPV type, and in some people HPV infection persists.
  • Persistent HPV infection is associated with the development of precancerous lesions and cancer. HPV types are classified as either high risk or low risk based on whether their persistence will lead to cancer.
  • Patients who have suppressed immune systems are at a higher risk for HPV-related complications. They are more likely to contract multiple HPV types and have more persistent infection that can lead to precancerous lesions or cancer, which are then difficult to treat and often recur.
  • A recently approved vaccine for HPV induces immunity to HPV 6, 11, 16, and 18. It was shown to be highly effective in preventing infection with these HPV types, and is approved for use in females 9 to 26 years of age. However, much less is known about the vaccines ability to induce immunity in males or individuals with suppressed immune systems.
Read more

Objectives:

  • To investigate whether the HPV vaccine is safe to give and able to induce immunity in both female and male adolescents and young adults with HIV infection compared to healthy, human immunodeficiency virus (HIV)-negative persons of the same age.

Eligibility:

  • Males and females, 12 to 26 years of age, divided into three groups: (1) Healthy and HIV-negative, (2) HIV-positive and on antiretroviral therapy, and (3) HIV-positive and not on antiretroviral therapy.

Design:

  • Before beginning vaccination, participants will have a complete physical examination and blood drawn for routine blood tests, special tests of the immune system, antibody tests, and an HIV test.
  • HPV vaccine will be given by injection into the muscle at 0, 2, and 6 months, according to the standard vaccination schedule.
  • Patients with HIV infection will be monitored for a week following the first injection to test the level of HIV in the blood 3 days and 5 days after the first injection.
  • Participants will also be asked to fill out a 10- to 15-minute Web-based survey about awareness, health behaviors, and personal choices related to risk factors for HIV, HPV, and other sexually transmitted diseases. Participants are not required to fill out the survey to receive the vaccine.
  • The total duration of the study is 4 years. During the first year of the study, participants will return for six additional 1-day visits at months 1, 2, 3, 6, 7, and 12. Participants will return for 1-day visits every 6 months for the remaining 3 years.
Read the detailed description

Background:

Human papilloma virus (HPV) is one of the most common sexually transmitted diseases and a significant cause of cutaneous genital warts and anogenital cancer.

Infection with high-risk, oncogenic HPV types, most commonly types 16 and 18, is associated with low and high-grade cervical cellular abnormalities that are precursors to invasive cervical cancer, as well as vulvar and anal cancer, while HPV types 6 and 11 are associated with genital warts.

Persistence of HPV infection is more common in individuals with or at risk for chronic immunosuppression and HIV-infected individuals have a higher prevalence of HPV infection and HPV-associated anogenital disease compared to age-matched human immunodeficiency virus (HIV)-negative controls.

Study Objectives:

To assess the safety and immunogenicity of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in HIV-infected preadolescents, adolescents and young adults 12-26 years of age.

To determine whether there are differences in HPV vaccine immunogenicity between HIV-infected and HIV negative age-matched controls.

To determine whether there are differences in HPV vaccine immunogenicity between HIV-infected patients receiving highly active antiretroviral therapy (HAART) and those not receiving HAART with similar cluster of differentiation 4 (CD4) and viral load parameters at entry.

To determine whether HPV vaccination alters human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) levels.

To investigate the impact of CD4 count and HIV-1 RNA levels on HPV vaccine immunogenicity.

To characterize HPV deoxyribonucleic acid (DNA) positivity in the study cohort populations through oral/buccal and anogenital sampling at baseline.

To characterize HPV and HIV knowledge and risk and sexual behaviors in the study cohort populations.

Eligibility:

Individual Cohorts

Cohort 1: HIV-positive, CD4 cell count greater than or equal to 350 cells/mm^3, HIV-1 RNA level by reverse transcription (RT) polymerase chain reaction (PCR) less than or equal to 20,000 copies/ml, on stable HAART regimen for greater than or equal to 6 months.

Cohort 2: HIV-infected, CD4 cell count greater than or equal to 500 cells/mm^3, HIV-1 RNA level by RT PCR less than or equal to 20,000 copies/ml, on no antiretroviral treatment.

Cohort 3: healthy, HIV-negative controls All Cohorts

Females and males age 12 to 26 years

Patients must have a hemoglobin greater than or equal to 10.0 gm/dL, neutrophil count (ANC) greater than or equal to 1500/mm^3, platelet count greater than or equal to 75,000/mm^3 and prothrombin time (PT) or partial thromboplastin time (PTT) less than or equal to 1.5x upper limit of normal (ULN) (with the exception of patients with known clotting disorders or lupus anticoagulant); serum glutamic-pyruvic transaminase (SGPT)/Serum glutamic oxaloacetic transaminase (SGOT) < 2/5x ULN, total bilirubin less than or equal to 1.5x ULN unless attributable to protease inhibitor therapy.

Patients must test negative for hepatitis B virus and hepatitis C virus, unless the result is consistent with prior vaccination or prior infection with full recovery.

No use of investigational agents within 4 weeks of study enrollment or use of immunosuppressive or immunomodulating agents within 8 weeks of study entry.

Study Design:

This is a non-randomized, prospective, phase I study of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine.

The study includes 3 cohorts of pre-adolescents, adolescents and young adults 12-26 years of age as outlined under Eligibility Criteria. Each cohort will enroll 35 patients.

All study subjects will receive three doses of HPV vaccine at 0, 2 and 6 months administered IM.

Study participants will be monitored at months 0, 1, 2, 3, 6, 7, and 12 (+/- 2 weeks for each visit, and every 6 months (+/- 30 days) thereafter for 48 months total.

Being tested
Gardasil, Survey
Keywords
HPV Vaccination, HPV Immunogenicity, HIV Infection, HIV Negative, Adolescents and Young Adults, Healthy Volunteer, HV, Adolescent
Medical subject headings
Acquired Immunodeficiency Syndrome, HIV Infections

What participants receive

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

  • GardasilBiological

    Also called Human Papillomavirus 9-valent Vaccine, Recombinant

    .5 mL dose injected intramuscular (IM) at 0, 2 and 6 months

  • SurveyBehavioural

    Administration of online risk behavior and knowledge survey done at week 0.

Study groups in NCT00798265
Study groupRoleWhat they receive
Cohort 1 - 0.5 mL dose injected intramuscular (IM)Experimental0.5 mL dose injected intramuscular (IM) at 0, 2 and 6 months (+/- 2 weeks) and knowledge survey at week 0
Receives: Biological: Gardasil; Behavioral: Survey
Cohort 2 - 0.5 mL dose injected intramuscular (IM)Experimental0.5 mL dose injected intramuscular (IM) at 0, 2 and 6 months (+/- 2 weeks) and knowledge survey at week 0
Receives: Biological: Gardasil; Behavioral: Survey
Cohort 3 - 0.5 mL dose injected intramuscular (IM)Active comparator0.5 mL dose injected intramuscular (IM) at 0, 2 and 6 months (+/- 2 weeks) and knowledge survey at week 0
Receives: Biological: Gardasil; Behavioral: Survey

What is being measured

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

  1. Immunogenicity of the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine in Human Immunodeficiency Virus (HIV)-Infected Preadolescents, Adolescents and Young Adults 12-26 Years of Age

    Immunogenicity was measured by the vaccine-induced antibody response collectively for preadolescents, adolescents and young adults an reported per cohort for participants with HIV and without HIV. Participants' serum was used to check the level of human papillomavirus (HPV) neutralization antibody. Neutralizing antibody is an antibody that can bind to the infectious organism such as viruses and stop the spread of the disease. The antibody level was compared between the participants with HIV and without HIV.

    Measured: Up to 36 months

Secondary outcomes (14)

  1. Human Papilloma Virus (HPV) Vaccine Immunogenicity Between Human Immunodeficiency Virus (HIV)-Infected Participants Receiving Highly Active Antiretroviral Therapy (HAART) & Those Not Receiving HAART With Similar T-lymphocytes (CD4) & Viral Load Parameters

    Match per the HIV level at study entry to compare between cohort 1 and 2.

    Measured: At study entry

  2. Number of Participants With Log Change in Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels After Human Papilloma Virus (HPV) Vaccination

    Within each cohort, the number of participants with a change in log^10 HIV-1 RNA levels will be determined between day 1 and day 7 and will be evaluated to see if the values at the two time points are not statistically different from one another. HIV-1 RNA levels below the lower limits of detection (50 copies/ml) will be expressed as 1.69 log^10 on a logarithmic scale equivalent to 49 copies/ml. There is at least 95% power to detect a change from day 1 to day 7 with an effect size of 1 standard deviation (SD) and a 0.025 two-sided alpha level test (0.05/2 cohorts) after allowing for a Bonferroni adjustment.

    Measured: Baseline, and months 1, 3, 7 and 12

  3. Fold Change in Anti-Human Papilloma Virus (HPV) Titer and T-lymphocytes (CD4) Count (Only at Baseline)

    Fold change in anti-HPV titer with baseline T-lymphocytes (CD4) count. Fold change is a measure of the antibody titer after vaccination divided by the baseline titer.

    Measured: Months 7, 12, 24 and 36

  4. T-lymphocytes (CD4) Count (Only at Baseline)

    Baseline T-lymphocytes (CD4) count.

    Measured: Baseline

  5. Number of Participants With Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) Positivity by Oral/Buccal Swabs at Baseline in the Study Cohort Populations

    Human papillomavirus (HPV) deoxyribonucleic acid (DNA) positivity by oral/buccal swabs was performed by swabbing the oral/buccal mucosa and

    Measured: Baseline

  6. Number of Participants With Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Positivity by Anogenital Swabs

    HPV DNA positivity by anogenital swabs was performed by Papanicolaou test (PAP) test. PAPs were not conducted when the participant stated that she was not sexually active.

    Measured: Up to 36 months

  7. Number of Participants Who Completed The Youth Risk Behavior Surveillance System (YRBSS)

    Here are the number of participants who properly completed (i.e., answered correctly) the YRBSS. The human papilloma virus (HPV) \& human immunodeficiency virus (HIV) knowledge and risk and sexual behaviors was assessed by a middle school or high school version of web-based Youth Risk Behavior Survey developed by Centers for Disease Control and Prevention (CDC). The Youth Risk Behavior Surveillance System (YRBSS) developed by the CDC was used to monitor six categories of priority health risk behaviors among middle school and high school youth: behaviors that contribute to unintentional injuries and violence; tobacco use; alcohol and other drug use; sexual behaviors that contribute to unintended pregnancy and sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV) infections; unhealthy dietary behaviors; and physical inactivity and determine the number of participants who answered correctly on the assessment tool (i.e., YRBSS).

    Measured: Baseline

  8. Number of Participants With Serum for Human Papilloma Virus (HPV) Antibody Titers Performed by Merck (Competitive Luminex Assay)

    Participants collection Tube: 10ml red top tube (RTT) send via courier to National Cancer Institute (NCI) FCRF for processing, aliquoting and cryopreservation by Baselar lab. Batched specimens to be sent to Merck for HPV antibody titers.

    Measured: 0, 1, 2, 3, 6, 7, 12, 18, 24, 30, 36, 42, and 48 hours

  9. Functional Human Papilloma Virus (HPV) Antibody Neutralization Assays

    Month 7 anti-HPV Ab titer was correlated with Neutralization Assay (PBNA) antibody titers and analyzed by the secreted alkaline phosphatase (SEAP)/enzyme-linked immunosorbent assay (ELISA) R.

    Measured: At 7 months

  10. Cryopreserved Peripheral Blood Mononuclear Cells (PBMCs) for Human Papilloma Virus (HPV) & Human Immunodeficiency Virus (HIV) Lymphocyte Proliferation Assays, Cytokine Induction Assay, Luminex Multi-cytokine Profiling of PBMCs

    Participants collection tube: 6 tubes sodium heparin 10ml green top tube (GTT) (60ml total) send via courier to National Cancer Institute (NCI) FCRF for processing, aliquoting and cryopreservation by Baselar lab according to protocol provided by the investigator. Note: HIV lymphocyte proliferation assays will only be performed in HIV-infected subjects

    Measured: 0, 1, 3, 7, 12, 24, 36, and 48 hours

  11. Extended Fluorescence Activated Cell Sorting (FACS)/Quantitative Lymphocyte Subpopulation Studies

    Extended FACS/Quantitative lymphocyte subpopulation studies human immunodeficiency virus (HIV)-infected subjects only (Cohorts 1 and 2) using a 10ml sodium heparin green top tube (GTT).

    Measured: 0, 1, 3, 7, 12, 18, 24, 30, 36, 42, and 48 hours

  12. Quantitative Measurement of Human Immunodeficiency Virus (HIV)-Related Chemokines Macrophage Inflammatory Proteins (MIP)-1 Alpha (α), MIP-1 Beta (β) and Regulated Upon Activation, Normal T Cell Expressed and Presumably Secreted (RANTES)

    Collection tube: 10ml red top tube (RTT) send via courier to National Cancer Institute (NCI) FCRF for processing, aliquoting and cryopreservation by Baselar lab.

    Measured: 0, 1, 2, 3, 6, 7, 12, 18, 24, 30, 36, 42, and 48 hours

  13. Cryopreserved Whole Blood for Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) Testing

    Three collection tube: 6ml purple top ethylenediamine tetraacetic acid (EDTA) tubes (18ml total)

    Measured: 0, 7, 12, 24, 36, and 48 Months

  14. Research Assays Immunologic Responses for Human Immunodeficiency Virus (HIV) Infected Subjects Only

    Two collection tubes: 10ml sodium heparin green top tube (GTT) (20ml total) from HIV infected subjects only (Cohorts 1 and 2).

    Measured: Month 0 only

Timeline

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

  1. First posted26 Nov 2008 (estimated)
  2. Study start29 Jun 2009
  3. Primary completion22 Sep 2012
  4. Study completion4 Feb 2013

Why it stopped: Study closed due to low accrual.

Resources

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 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00798265
Sponsor's protocol ID
090024
Other IDs
09-C-0024
Status last verified
Nov 2024
First submitted
25 Nov 2008
Last updated
20 Nov 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.

Publications

  • Koutsky LA, Galloway DA, Holmes KK. Epidemiology of genital human papillomavirus infection. Epidemiol Rev. 1988;10:122-63. doi: 10.1093/oxfordjournals.epirev.a036020.

    PubMed 2852116

  • Munoz N, Bosch FX, de Sanjose S, Herrero R, Castellsague X, Shah KV, Snijders PJ, Meijer CJ; International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003 Feb 6;348(6):518-27. doi: 10.1056/NEJMoa021641.

    PubMed 12571259

  • Koshiol JE, Laurent SA, Pimenta JM. Rate and predictors of new genital warts claims and genital warts-related healthcare utilization among privately insured patients in the United States. Sex Transm Dis. 2004 Dec;31(12):748-52. doi: 10.1097/01.olq.0000145851.76025.ad.

    PubMed 15608590

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gardasil and Survey in people with Human Immunodeficiency Virus and Human Papillomavirus- 6, 11, 16, 18, run by National Cancer Institute (NCI) at 1 site in United States.

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 26 inclusion and 54 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: stopped early, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 20 Nov 2024). 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?

Immunogenicity of the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine in Human Immunodeficiency Virus (HIV)-Infected Preadolescents, Adolescents and Young Adults 12-26 Years of Age (time frame: Up to 36 months). 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 NCT00798265, which also lists 3 linked publications.

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 20 Nov 2024.

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