HIV InfectionsNCT00006444
The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women
An observational study of HIV Infections and Papilloma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 51 sites in 2 countries.
Trial summary
The purpose of this study is to see how often human papillomavirus (HPV) occurs in HIV-infected women who have not taken anti-HIV drugs and to learn whether taking anti-HIV drugs will affect HPV in women. HIV infection increases the risk of getting HPV infection. Read more about this study
- Who is it for?
- Ages 13 years and older, women only
- Conditions the study is for
- HIV Infections, Papilloma
- How many people
- 160 participants
- Where
- 51 sitesin 2 countries
- Study dates
- Nov 2000to Aug 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
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 13 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women may be eligible for this study if they:
- Are HIV-positive.
- Are at least 13 years of age and menstruating.
- Are willing to enroll in another drug study.
- Have written consent of a parent or guardian if under 18 years.
- This study has been changed to increase enrollment. Women who are starting HAART-based therapy prescribed by a personal physician or participating in an antiretroviral trial are all eligible.
- Intend to start antiretroviral therapy within 14 days of study entry.
Who cannot join
- Women will not be eligible for this study if they:
- Have been on anti-HIV treatment for more than 14 days.
- Are abusing drugs or alcohol.
- Are receiving medication that affects the immune system, fights HPV, or is investigational, except for anti-HIV drugs provided by coenrolling in a Phase II or III trial with approval of a study chair within 30 days of study entry, including but not limited to systemic interferons and interleukins, thalidomide, systemic cidofovir, and HPV vaccines. This study has been changed. The following medications are no longer excluded: thymopentin, hydroxyurea, granulocyte colony-stimulating factor (G-CSF and filgrastim), and GM-CSF (sargramostim).
- Have cervical cancer or a history of cervical cancer.
- Have had a hysterectomy (removal of the uterus).
Show all 9Show fewer
- Participated in HPV trials at any time.
- Use imiquimod inside the vagina.
- Are taking corticosteroid treatment in large doses.
Trial locations and contacts
51 sites in 2 countries.
51 sites in 2 countries
United States49 sites
Emory Univ
Atlanta, Georgia, 30308
Univ of Maryland (Pediatric)
Baltimore, Maryland, 20201
Univ of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston Med Ctr (Harvard)
Boston, Massachusetts, 02118
Boston Med Ctr (Pediatric)
Boston, Massachusetts, 02118
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
Brigham and Women's Hosp
Boston, Massachusetts, 02215
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608
Northwestern Univ Med School
Chicago, Illinois, 60611
The CORE Ctr
Chicago, Illinois, 60612
Case Western Reserve Univ
Cleveland, Ohio, 44106
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
Univ of Colorado Health Sciences Ctr, Denver
Denver, Colorado, 80262-3706
Duke Univ Med Ctr
Durham, North Carolina, 27710
North Broward Hosp District
Fort Lauderdale, Florida, 33311
Univ of Hawaii
Honolulu, Hawaii, 96816
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
Wishard Hosp
Indianapolis, Indiana, 46202
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
UCLA CARE Ctr
Los Angeles, California, 90095
Univ of Miami School of Medicine
Miami, Florida, 331361013
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136
Univ of Miami (Pediatric)
Miami, Florida, 33161
Beth Israel Med Ctr
New York, New York, 10003
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Columbia Presbyterian Med Ctr
New York, New York, 10032
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906
Brown Univ / The Miriam Hosp
Providence, Rhode Island, 02906
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906
Community Health Network
Rochester, New York, 14642-001
Univ of Rochester Medical Center
Rochester, New York, 14642
Univ of California, San Diego
San Diego, California, 92103
University of California San Francisco
San Francisco, California, 941104206
University of Washington (Seattle)
Seattle, Washington, 98104
San Mateo County AIDS Program
Stanford, California, 94305-5107
Stanford Univ
Stanford, California, 94305-5107
Willow Clinic
Stanford, California, 94305-5107
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, 10467
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
Julio Arroyo
West Columbia, South Carolina, 29169
Puerto Rico2 sites
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067
San Juan City Hosp
San Juan, 009367344
About this study
Official title: Assessment of Prevalence and Persistence of Human Papillomavirus (HPV) DNA in HIV-Infected Women Who Are Antiretroviral Naive and Have Initiated HAART
The purpose of this study is to see how often human papillomavirus (HPV) occurs in HIV-infected women who have not taken anti-HIV drugs and to learn whether taking anti-HIV drugs will affect HPV in women.
HIV infection increases the risk of getting HPV infection. Findings suggest that HIV infection as well as a weakened immune system may increase the chances of getting HPV. Aggressive anti-HIV medication has been shown to strengthen the immune system. Researchers want to learn whether anti-HIV drugs affect the HPV virus or decrease the chances of getting HPV. This study is important because it may provide important information to help manage a woman's health and to determine a woman's risk for developing problems with the cervix (outer end of the uterus).
Read the detailed description
HIV infection is a significant risk factor for human HPV infection and the development of HPV-associated lesions in the female genital tract. Findings suggest that HIV infection and/or HIV-related immunosuppression increases a woman's susceptibility to HPV infection or alters the natural history of preexisting HPV infection. Treatment with HAART has been shown to result in significant increases in CD4+ cell counts and "partial reconstitution" of the immune system. It is not known whether treatment of HIV infection with potent antiretroviral regimens could affect the persistence of HPV infection and progression of cervical dysplasia. This study is important for HIV-infected women because of the implications for gynecologic management and determination of cervical disease risk.
At baseline, Weeks 24 and 48, and then every 48 weeks until study completion, women undergo pelvic examination and cervical specimens collection by the following methods: 1) Sno-strip; 2) cervicovaginal lavage; 3) cervical brush method; and 4) Pap smear. A colposcopy is required for any woman who has an abnormal Pap smear reading unless the abnormal Pap smear is thought to be due to an intercurrent infection. A cervical biopsy is strongly recommended in the event of an abnormal colposcopy. Blood is collected for HPV antibody testing, viral load, and CD4 measures.
- Conditions
- HIV Infections, Papilloma
- Keywords
- Drug Therapy, Combination, Papillomavirus, Human, DNA, Viral, Anti-HIV Agent, Treatment Naive
- Medical subject headings
- HIV Infections, Papilloma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startNov 2000
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 160 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Kathleen Squires, Study chairRebecca Clark, Study chairKenneth H Fife, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006444
- Sponsor's protocol ID
- A5029
- Other IDs
- AACTG A5029, ACTG A5029
- Status last verified
- Nov 2013
- First submitted
- 3 Nov 2000
- Last updated
- 20 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Prevalence and Persistence of Human Papillomavirus (HPV) DNA in HIV-Infected Women Who Are Antiretroviral Naive and Have Initiated HAART
- ClinicalTrials.gov ID
- NCT00006444
- Acronym / sponsor ID
- A5029
- Conditions
- HIV Infections, Papilloma
- Keywords
- Drug Therapy, Combination, Papillomavirus, Human, DNA, Viral, Anti-HIV Agent, Treatment Naive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Nov 2000
- Study completion
- Aug 2005 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see how often human papillomavirus (HPV) occurs in HIV-infected women who have not taken anti-HIV drugs and to learn whether taking anti-HIV drugs will affect HPV in women.
HIV infection increases the risk of getting HPV infection. Findings suggest that HIV infection as well as a weakened immune system may increase the chances of getting HPV. Aggressive anti-HIV medication has been shown to strengthen the immune system. Researchers want to learn whether anti-HIV drugs affect the HPV virus or decrease the chances of getting HPV. This study is important because it may provide important information to help manage a woman's health and to determine a woman's risk for developing problems with the cervix (outer end of the uterus).
Detailed description
HIV infection is a significant risk factor for human HPV infection and the development of HPV-associated lesions in the female genital tract. Findings suggest that HIV infection and/or HIV-related immunosuppression increases a woman's susceptibility to HPV infection or alters the natural history of preexisting HPV infection. Treatment with HAART has been shown to result in significant increases in CD4+ cell counts and "partial reconstitution" of the immune system. It is not known whether treatment of HIV infection with potent antiretroviral regimens could affect the persistence of HPV infection and progression of cervical dysplasia. This study is important for HIV-infected women because of the implications for gynecologic management and determination of cervical disease risk.
At baseline, Weeks 24 and 48, and then every 48 weeks until study completion, women undergo pelvic examination and cervical specimens collection by the following methods: 1) Sno-strip; 2) cervicovaginal lavage; 3) cervical brush method; and 4) Pap smear. A colposcopy is required for any woman who has an abnormal Pap smear reading unless the abnormal Pap smear is thought to be due to an intercurrent infection. A cervical biopsy is strongly recommended in the event of an abnormal colposcopy. Blood is collected for HPV antibody testing, viral load, and CD4 measures.
Study design
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Are HIV-positive.
- Are at least 13 years of age and menstruating.
- Are willing to enroll in another drug study.
- Have written consent of a parent or guardian if under 18 years.
- This study has been changed to increase enrollment. Women who are starting HAART-based therapy prescribed by a personal physician or participating in an antiretroviral trial are all eligible.
Key exclusion criteria (9 listed)
- Have been on anti-HIV treatment for more than 14 days.
- Are abusing drugs or alcohol.
- Are receiving medication that affects the immune system, fights HPV, or is investigational, except for anti-HIV drugs provided by coenrolling in a Phase II or III trial with approval of a study chair within 30 days of study entry, including but not limited to systemic interferons and interleukins, thalidomide, systemic cidofovir, and HPV vaccines. This study has been changed. The following medications are no longer excluded: thymopentin, hydroxyurea, granulocyte colony-stimulating factor (G-CSF and filgrastim), and GM-CSF (sargramostim).
- Have cervical cancer or a history of cervical cancer.
- Have had a hysterectomy (removal of the uterus).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Squires study chair
Rebecca Clark study chair
Kenneth H Fife study chair
51 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Papilloma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 51 sites in 2 countries.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Puerto Rico. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 2013.