Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00604175
First received: January 17, 2008
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

Human papillomavirus (HPV) is the most common sexually transmitted disease in the world. HPV infection can cause genital warts and certain cervical problems, including cervical cancer. HPV infection may be more severe and harder to treat in HIV-infected people. The purpose of this study is to determine whether the quadrivalent HPV vaccine is safe, tolerable, and effective in producing antibodies to HPV in HIV-infected women.


Condition Intervention Phase
HIV Infections
Sexually Transmitted Diseases
Biological: Quadrivalent HPV vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Females

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Percentage of Participants With HPV6 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
    Percentage of participants with HPV6 antibody development from seronegative status (HPV6 antibody titers <20 mMU/mL) at baseline to seropositive (HPV6 antibody titers >=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.

  • Percentage of Participants With HPV11 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
    Percentage of participants with HPV11 antibody development from seronegative status (HPV11 antibody titers <16 mMU/mL) at baseline to seropositive (HPV11 antibody titers >=16 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.

  • Percentage of Participants With HPV16 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
    Percentage of participants with HPV16 antibody development from seronegative status (HPV16 antibody titers <20 mMU/mL) at baseline to seropositive (HPV16 antibody titers >=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.

  • Percentage of Participants With HPV18 Antibody Development From the Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
    Percentage of participants with HPV18 antibody development from seronegative status (HPV18 antibody titers <24 mMU/mL) at baseline to seropositive (HPV18 antibody titers >=24 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.


Secondary Outcome Measures:
  • HPV6 Antibody Titers Among Those Seronegative for HPV6 at Baseline [ Time Frame: Weeks 28, 72 ] [ Designated as safety issue: No ]
    HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6). Geometric mean HPV6 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV6 (<20 mMU/mL) at baseline. Only Week 28 results are reported at this time. The summary will be updated to include Week 72 data when available.

  • HPV11 Antibody Titers Among Those Seronegative for HPV11 at Baseline [ Time Frame: Weeks 28, 72 ] [ Designated as safety issue: No ]
    HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11). Geometric mean HPV11 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV11 (<16 mMU/mL) at baseline. Only Week 28 results are reported at this time. The summary will be updated to include Week 72 data when available.

  • HPV16 Antibody Titers Among Those Seronegative for HPV16 at Baseline [ Time Frame: Weeks 28, 72 ] [ Designated as safety issue: No ]
    HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16). Geometric mean HPV16 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV16 (<20 mMU/mL) at baseline. Only Week 28 results are reported at this time. The summary will be updated to include Week 72 data when available.

  • HPV18 Antibody Titers Among Those Seronegative for HPV18 at Baseline [ Time Frame: Weeks 28, 72 ] [ Designated as safety issue: No ]
    HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18). Geometric mean HPV18 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV18 (<24 mMU/mL) at baseline. Only Week 28 results are reported at this time. The summary will be updated to include Week 72 data when available.

  • Change in Log10 HPV6 Antibody Titers From Baseline Among Those Seropositive for HPV6 at Baseline [ Time Frame: Weeks 0, 28, 72 ] [ Designated as safety issue: No ]
    Change in log10 HPV6 antibody titers was calculated as log10 HPV6 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV6 antibody titers at baseline among those seropositive for HPV6 (>=20 mMU/mL) at baseline. HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6). The present summary is based on the time-frame from baseline to Week 28. The summary will be updated to include Week 72 data when available.

  • Change in Log10 HPV11 Antibody Titers From Baseline Among Those Seropositive for HPV11 at Baseline [ Time Frame: Weeks 0, 28, 72 ] [ Designated as safety issue: No ]
    Change in log10 HPV11 antibody titers was calculated as log10 HPV11 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV11 antibody titers at baseline among those seropositive for HPV11 (>=16 mMU/mL) at baseline. HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11). The present summary is based on the time-frame from baseline to Week 28. The summary will be updated to include Week 72 data when available.

  • Change in Log10 HPV16 Antibody Titers From Baseline Among Those Seropositive for HPV16 at Baseline [ Time Frame: Weeks 0, 28, 72 ] [ Designated as safety issue: No ]
    Change in log10 HPV16 antibody titers was calculated as log10 HPV16 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV16 antibody titers at baseline among those seropositive for HPV16 (>=20 mMU/mL) at baseline. HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16). The present summary is based on the time-frame from baseline to Week 28. The summary will be updated to include Week 72 data when available.

  • Change in Log10 HPV18 Antibody Titers From Baseline Among Those Seropositive for HPV18 at Baseline [ Time Frame: Weeks 0, 28, 72 ] [ Designated as safety issue: No ]
    Change in log10 HPV18 antibody titers was calculated as log10 HPV18 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV18 antibody titers at baseline among those seropositive for HPV18 (>=24 mMU/mL) at baseline. HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18). The present summary is based on the time-frame from baseline to Week 28. The summary will be updated to include Week 72 data when available.

  • Number of Participants With Signs and Symptoms of Grade 3 or Higher [ Time Frame: From baseline to up to Week 72 ] [ Designated as safety issue: Yes ]
    Number of participants who experienced a sign or symptom of Grade 3 or higher at any time after baseline while on study. The present summary is based on the time-frame from baseline to Week 28. The summary will be updated to include data up to Week 72 when available. Grading of signs and symptoms was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.

  • Number of Participants With Laboratory Abnormalities of Grade 3 or Higher [ Time Frame: From baseline to up to Week 72 ] [ Designated as safety issue: Yes ]
    Number of participants who experienced a laboratory abnormality of Grade 3 or higher at any time after baseline while on study. The present summary is based on the time-frame from baseline to Week 28. The summary will be updated to include data up to Week 72 when available. Grading of laboratory abnormalities was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.

  • Change in Log10 HIV Viral Load (VL) From Baseline [ Time Frame: Weeks 0, 4, 12, 28, 52, and 72 ] [ Designated as safety issue: No ]
    A blood sample was drawn for local testing to determine the HIV VL. Change in log10 HIV VL was calculated as log10 HIV VL at a later time point (Weeks 4, 12, 28, 52 and 72) minus log10 HIV VL at baseline. The present summary is based on the time-frame from baseline to Week 28. The summary will be updated to include data up to Week 72 when available.

  • Change in CD4 Cell Count From Baseline [ Time Frame: Weeks 0, 4, 8, 12, 24, 28, 52 and 72 ] [ Designated as safety issue: No ]
    A blood sample was drawn for local testing to determine the CD4 cell count. Change in CD4 cell count was calculated as CD4 cell count at a later time point (Weeks 4, 8, 12, 24, 28, 52 and 72) minus CD4 cell count at baseline. The present summary is based on the time-frame from baseline to Week 28. The summary will be updated to include data up to Week 72 when available.


Enrollment: 319
Study Start Date: February 2008
Study Completion Date: November 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stratum A
Participants with screening CD4 count >350 cells/mm3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Biological: Quadrivalent HPV vaccine
Quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine. All participants received the vaccine via intramuscular injection at baseline, Week 8 and Week 24.
Other Name: GARDASIL
Experimental: Stratum B
Participants with screening CD4 count >200 to <=350 cells/mm3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Biological: Quadrivalent HPV vaccine
Quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine. All participants received the vaccine via intramuscular injection at baseline, Week 8 and Week 24.
Other Name: GARDASIL
Experimental: Stratum C
Participants with screening CD4 count <=200 cells/mm3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Biological: Quadrivalent HPV vaccine
Quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine. All participants received the vaccine via intramuscular injection at baseline, Week 8 and Week 24.
Other Name: GARDASIL

Detailed Description:

HPV is a DNA virus that affects both men and women. Approximately 90 types of HPV have been identified, 30 of which are sexually transmitted. The most common forms of HPV are types 6, 11, 16, and 18. The quadrivalent HPV vaccine that was tested in this study had been shown in previous studies to be effective in preventing infection with HPV 6, 11, 16, and 18 in healthy young women. According to a report by the Centers for Disease Control and Prevention (CDC), 80% of women will have acquired HPV by the age of 50. HIV infected women have been reported to have a higher prevalence and persistence of HPV infection, as well as an increased risk for abnormal Pap smears and cervical cancer. HPV types 16 and 18 cause the majority of cervical cancers worldwide, and types 6 and 11 are responsible for the majority of cases of genital warts. Vaccinations for preventable infections are particularly important among HIV infected people because people with HIV have compromised immune systems; therefore, any infection is very serious and can potentially be fatal. However, standard vaccination series have not been very successful because a compromised immune system may not produce the desired immune response to a vaccine. The HPV vaccine is designed to protect against infection with HPV types 6, 11, 16, and 18 and has been approved by the FDA for use in women between the ages of 9 and 26. The purpose of this study was to determine whether the quadrivalent HPV vaccine is safe, tolerable, and effective in producing antibodies to HPV in HIV infected females.

The study consisted of single arm evaluations of HPV vaccine immunogenicity and safety in 3 groups based on the study screening CD4 cell count as follows:

  • Stratum A: CD4 cell count >350 cells/mm3
  • Stratum B: CD4 cell count >200 to <=350 cells/mm3
  • Stratum C: CD4 cell count <=200 cells/mm3

In Version 1.0 of the protocol, the target accrual was n=67 participants with screening HIV viral load <=10,000 copies/mL and n=67 participants with HIV viral load >10,000 copies/mL within each CD4 stratum, yielding n=134 in each CD4 stratum. In light of subsequent findings from completed HPV vaccine studies, the sample size was changed to n=94 participants per CD4 stratum in Version 2.0 of the protocol, and stratification by screening HIV viral load was removed. All Stratum A and Stratum B participants were enrolled under protocol Version 1.0.

The study duration was 72 weeks. All participants received HPV vaccine administered by intramuscular injection at baseline, and at Weeks 8 and 24. Following each injection, participants remained at the clinic for 30 minutes of observation for adverse events. A telephone follow-up or a home visit by study staff was performed within 2 days following each injection.

Participants returned to the clinic for visits at Weeks 4, 8, 12, 24, 28, 52, and 72. Most study visits included a physical exam, medication review, blood and urine collection, and answering questions about signs and symptoms since previous visit. Some visits included measurement of HIV viral load and CD4 cell count; collection of endocervical wick, cervical cytobrush and anal swab; and an oral exam. A subset of participants were asked to provide additional blood samples and oral cytobrush specimens.

  Eligibility

Ages Eligible for Study:   13 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infection
  • CD4 count obtained within 45 days prior to study entry
  • Karnofsky performance score >=70 on at least one occasion within 45 days prior to study entry
  • The following labs within 45 days prior to study entry:

    • hemoglobin >8.0 g/dL
    • direct bilirubin <2.5 x upper limit of normal (ULN)
    • alanine aminotransferase, ALT (SGPT) <3 xULN
    • aspartate aminotransferase, AST (SGOT) <3 xULN
    • platelet count >=100,000 /mm3
  • Willing to use acceptable forms of contraception for the duration of the study
  • Written informed consent from participant or from parent or guardian, if applicable
  • If on HAART, then the same regimen for at least 12 weeks prior to study entry with no change within 30 days prior to study entry. (This criterion was removed in Version 2.0 of the protocol.)
  • HIV viral load obtained within 45 days prior to study entry (This criterion was removed in Version 2.0 of the protocol.)

Exclusion Criteria:

  • Abnormal Pap test with confirmed biopsy results of cervical intraepithelial neoplasia (CIN) II or III or cervical cancer within 180 days prior to study entry
  • Vulval intraepithelial neoplasia (VIN) II or III or cancer confirmed by biopsy results within 180 days prior to study entry
  • Physician-diagnosed genital warts within 180 days prior to study entry
  • Previous cervical dysplasia treatment, including loop electrosurgical excision procedure (LEEP), cervical cryotherapy, cone biopsy, and cervical laser vaporization within 180 days prior to study entry
  • Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin (IVIG) within 45 days prior to study entry. Participants who had received standard of care (e.g., hepatitis B, influenza, and tetanus) vaccines were not excluded.
  • Known allergy or hypersensitivity to yeast or any components of the vaccine or its formulation
  • Current drug or alcohol use or dependence or any other condition that may interfere with study participation
  • Serious illness requiring systemic treatment and/or hospitalization within 45 days prior to study entry
  • Total hysterectomy. Participants who had undergone partial hysterectomy and had a cervix were not excluded.
  • Hemophilia
  • Currently on anticoagulation therapy other than acetylsalicylic acid
  • Prior vaccination with an HPV vaccine
  • Pregnant or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604175

  Hide Study Locations
Locations
United States, Alabama
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294-2050
United States, California
Usc La Nichd Crs
Alhambra, California, United States, 90033
Miller Children's Hosp. Long Beach CA NICHD CRS
Long Beach, California, United States, 90806
USC CRS
Los Angeles, California, United States, 90033
UCLA CARE Center CRS
Los Angeles, California, United States, 90035
Stanford CRS
Palo Alto, California, United States, 94304-5350
Ucsd, Avrc Crs
San Diego, California, United States, 92103
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States, 92103
Ucsf Aids Crs
San Francisco, California, United States, 94110
United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80045
Denver Public Health CRS
Denver, Colorado, United States, 80204
United States, District of Columbia
Georgetown University CRS (GU CRS)
Washington, District of Columbia, United States, 20007
Howard Univ. Washington DC NICHD CRS
Washington, District of Columbia, United States, 20060
United States, Florida
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, United States, 33316
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209
Univ. of Miami AIDS CRS
Miami, Florida, United States, 33136
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States, 33136
United States, Georgia
The Ponce de Leon Ctr. CRS
Atlanta, Georgia, United States, 30308
United States, Illinois
Northwestern University CRS
Chicago, Illinois, United States, 60611
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
Chicago, Illinois, United States, 60608
Rush Univ. Cook County Hosp. Chicago NICHD CRS
Chicago, Illinois, United States, 60612
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane Univ. New Orleans NICHD CRS
New Orleans, Louisiana, United States, 70112
United States, Maryland
IHV Baltimore Treatment CRS
Baltimore, Maryland, United States, 21201
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States, 02215
Bmc Actg Crs
Boston, Massachusetts, United States, 02118
United States, Michigan
Henry Ford Hosp. CRS
Detroit, Michigan, United States, 48202
United States, Missouri
Washington U CRS
St. Louis, Missouri, United States, 63110
United States, New Jersey
Cooper Univ. Hosp. CRS
Camden, New Jersey, United States, 08103
New Jersey Medical School- Adult Clinical Research Ctr. CRS
Newark, New Jersey, United States, 07103
United States, New York
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
Columbia IMPAACT CRS
New York, New York, United States, 10032
Cornell CRS
New York, New York, United States, 10011
HIV Prevention & Treatment CRS
New York, New York, United States, 10032
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
AIDS Care CRS
Rochester, New York, United States, 14607
United States, North Carolina
Unc Aids Crs
Chapel Hill, North Carolina, United States, 27514
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, United States, 27710
Regional Center for Infectious Disease, Wendover Medical Center CRS
Greensboro, North Carolina, United States, 27401
United States, Ohio
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States, 45267-0405
Case CRS
Cleveland, Ohio, United States, 44106
MetroHealth CRS
Cleveland, Ohio, United States, 44109
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Oregon
The Research & Education Group-Portland CRS
Portland, Oregon, United States, 97210
United States, Pennsylvania
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson Univ. Med. Ctr. CRS
Philadelphia, Pennsylvania, United States, 19107
Pitt CRS
Pittsburgh, Pennsylvania, United States, 15213-2582
United States, Rhode Island
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, United States, 02906
United States, Tennessee
Vanderbilt Therapeutics CRS
Nashville, Tennessee, United States, 37204
United States, Texas
Trinity Health and Wellness Center CRS
Dallas, Texas, United States, 75208
Texas Children's Hosp. CRS
Houston, Texas, United States, 77030
Houston AIDS Research Team CRS
Houston, Texas, United States, 77030
United States, Virginia
Virginia Commonwealth Univ. Medical Ctr. CRS
Richmond, Virginia, United States, 23298
United States, Washington
University of Washington AIDS CRS
Seattle, Washington, United States, 98104
Brazil
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, Brazil, 21040-900
Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 00936
University of Puerto Rico Pediatric HIV/AIDS Research Program CRS
San Juan, Puerto Rico, 00935
Puerto Rico-AIDS CRS
San Juan, Puerto Rico, 00935
South Africa
Wits HIV CRS
Johannesburg, Gauteng, South Africa, 2092
Sponsors and Collaborators
Investigators
Study Chair: Erna Milunka Kojic, MD Department of Immunology/Infectious Disease, The Miriam Hospital, Brown University
Study Chair: Susan Cu-Uvin, MD Obstetrics-Gynecology and Medicine, The Miriam Hospital, Brown University
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00604175     History of Changes
Other Study ID Numbers: A5240, 10393, ACTG A5240
Study First Received: January 17, 2008
Results First Received: July 15, 2013
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV
HPV 6
HPV 11
HPV 16
HPV 18
Vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 17, 2014