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Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00710593
First Posted: July 4, 2008
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
Results First Submitted: November 15, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: HIV Infection
Intervention: Biological: HPV vaccine for strains -6, -11, -16, and -18

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled between 2008 and 2011 at Adolescent Trials Network for HIV/AIDS Interventions (ATN) clinical sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
ART/HAART NAIVE Participants who are antiretroviral (ART) naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
HAART Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.

Participant Flow:   Overall Study
    ART/HAART NAIVE   HAART
STARTED   69   30 
COMPLETED   54 [1]   25 [2] 
NOT COMPLETED   15   5 
Incarceration                1                0 
Unable to complete Wk 48 within window                2                0 
Lost to Follow-up                3                1 
Moved out of area                1                0 
Failure to adhere or complete study eval                1                1 
Protocol Violation                1                1 
Prem disc vaccine, completed all visits                6                2 
[1] 54 completed study and vaccine. 6 did not receive all vaccine, but completed all study visits.
[2] 25 completed study and vaccine. 2 did not receive all vaccine, but completed all study visits.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group A Participants who are antiretroviral (ART) naïve or, if ART-exposed, have not received highly active antiretroviral therapy(HAART) for at least the six months prior to study entry.
Group B Participants who have been receiving highly active retroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
Total Total of all reporting groups

Baseline Measures
   Group A   Group B   Total 
Overall Participants Analyzed 
[Units: Participants]
 69   30   99 
Age, Customized 
[Units: Participants]
     
< 20 years   16   6   22 
> = 20 years   53   24   77 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      69 100.0%      30 100.0%      99 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   63   29   92 
Puerto Rico   6   1   7 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   HPV-6 Antibody Level (Geometric Mean Titer of HPV-6)   [ Time Frame: Week 28 ]

2.  Primary:   HPV-11 Antibody Level (Geometric Mean Titer of HPV-11)   [ Time Frame: Week 28 ]

3.  Primary:   HPV-16 Antibody Level (Geometric Mean Titer of HPV-16)   [ Time Frame: Week 28 ]

4.  Primary:   HPV-18 Antibody Level (Geometric Mean Titer of HPV-18)   [ Time Frame: Week 28 ]

5.  Secondary:   Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-6   [ Time Frame: Week 28 ]

6.  Secondary:   Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-11   [ Time Frame: Week 28 ]

7.  Secondary:   Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-16   [ Time Frame: Week 28 ]

8.  Secondary:   Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-18   [ Time Frame: Week 28 ]

9.  Secondary:   Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine   [ Time Frame: Entry, Week 8, and Week 24 ]

10.  Secondary:   Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-6.   [ Time Frame: Week 48 ]

11.  Secondary:   Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-11.   [ Time Frame: Week 48 ]

12.  Secondary:   Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-16.   [ Time Frame: Week 48 ]

13.  Secondary:   Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-18.   [ Time Frame: Week 48 ]

14.  Secondary:   Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24).   [ Time Frame: Week 24 ]

15.  Secondary:   Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24).   [ Time Frame: Week 24 ]

16.  Secondary:   Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24).   [ Time Frame: Week 24 ]

17.  Secondary:   Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24).   [ Time Frame: Week 24 ]

18.  Secondary:   Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48).   [ Time Frame: Week 48 ]

19.  Secondary:   Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48).   [ Time Frame: Week 48 ]

20.  Secondary:   Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48).   [ Time Frame: Week 48 ]

21.  Secondary:   Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48).   [ Time Frame: Week 48 ]

22.  Secondary:   Percentage of Participants Who Reported a Lower Need to Practice Safe Sex Following HPV Vaccination and the Percentage of Participants That Reported a Higher Need to Practice Safe Sex Following HPV Vaccination   [ Time Frame: Week 48 ]

23.  Secondary:   Need for Safer Sexual Behaviors (NSSB) (Evaluated by Using the "12-item Knowledge About HPV and HPV Vaccine" Measure)   [ Time Frame: Week 48 ]

24.  Secondary:   Visit Compliance Via the Telephone Response System (TRS) Versus the Vaccine Report Card.   [ Time Frame: Day 1 through Week 24 ]

25.  Secondary:   Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC).   [ Time Frame: Day 1 through Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The small number of participants (99 started and 79 completed the study) limits generalizability of safety/tolerability data.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Bob Harris
Organization: Westat
phone: 301-251-1500
e-mail: bobharris@westat.com


Publications of Results:

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00710593     History of Changes
Other Study ID Numbers: ATN 064
First Submitted: July 2, 2008
First Posted: July 4, 2008
Results First Submitted: November 15, 2013
Results First Posted: May 22, 2017
Last Update Posted: July 2, 2017



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