HIV InfectionsNCT00069485
Resistance to HIV Infection
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The immune systems of some individuals may be capable of resisting HIV infection. These individuals do not appear to be infected with HIV despite multiple sexual encounters with HIV infected partners. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1995to not given
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health
- HIV uninfected
- Repeated exposures to HIV through unprotected sexual intercourse within the 2 years prior to study entry
- Live in the greater Seattle area
- Plan to stay in the greater Seattle area for the 2 years after study entry
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Fred Hutchinson Cancer Research Center / University of Washington HIV Vaccine Trials Unit
Seattle, Washington, 98104
Kim Louis, 206-667-2300, klouis@fhcrc.org
About this study
Official title: Evaluation of HIV-Specific Immunological and Virological Responses of HIV-1 Multiply-Exposed Seronegative Individuals
The immune systems of some individuals may be capable of resisting HIV infection. These individuals do not appear to be infected with HIV despite multiple sexual encounters with HIV infected partners. This study will examine the immune systems of these individuals to determine what factors are responsible for their ability to resist HIV infection.
Study hypothesis: Some long-term, multiply-exposed seronegative persons have relative resistance to HIV infection maintained by T cell responses.
Read the detailed description
Rare individuals appear naturally resistant to overt HIV-1 infection despite repeated sexual exposures. These individuals, referred to as exposed seronegatives (ES), represent a unique population in which to evaluate mechanisms by which HIV-1 replication is either controlled or aborted. The purpose of the study is to analyze HIV-specific immune responses, both cellular and humoral, that exist in seronegative individuals who have experienced multiple exposures to HIV by sexual contact.
This study will follow participants for 2 years. Participants will have 25 study visits during the study. Assessments will include HIV tests, viral load measurements, CD4 counts, pregnancy tests, and physical exams.
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2003 (estimated)
- Study startDec 1995
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
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Julie McElrath, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069485
- Sponsor's protocol ID
- 5R01AI047086-03
- Other IDs
- 5R01AI047086-03
- Status last verified
- Jul 2007
- First submitted
- 26 Sep 2003
- Last updated
- 18 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of HIV-Specific Immunological and Virological Responses of HIV-1 Multiply-Exposed Seronegative Individuals
- ClinicalTrials.gov ID
- NCT00069485
- Acronym / sponsor ID
- 5R01AI047086-03
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Dec 1995
- First posted
- 30 Sep 2003 (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 immune systems of some individuals may be capable of resisting HIV infection. These individuals do not appear to be infected with HIV despite multiple sexual encounters with HIV infected partners. This study will examine the immune systems of these individuals to determine what factors are responsible for their ability to resist HIV infection.
Study hypothesis: Some long-term, multiply-exposed seronegative persons have relative resistance to HIV infection maintained by T cell responses.
Detailed description
Rare individuals appear naturally resistant to overt HIV-1 infection despite repeated sexual exposures. These individuals, referred to as exposed seronegatives (ES), represent a unique population in which to evaluate mechanisms by which HIV-1 replication is either controlled or aborted. The purpose of the study is to analyze HIV-specific immune responses, both cellular and humoral, that exist in seronegative individuals who have experienced multiple exposures to HIV by sexual contact.
This study will follow participants for 2 years. Participants will have 25 study visits during the study. Assessments will include HIV tests, viral load measurements, CD4 counts, pregnancy tests, and physical exams.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Good general health
- HIV uninfected
- Repeated exposures to HIV through unprotected sexual intercourse within the 2 years prior to study entry
- Live in the greater Seattle area
- Plan to stay in the greater Seattle area for the 2 years after study entry
Key exclusion criteria (1 listed)
- Pregnancy
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2007.
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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.
Fred Hutchinson Cancer Research Center / University of Washington HIV Vaccine Trials Unit
Seattle, United States
Julie McElrath, MD, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Sep 2007. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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 18 Sep 2007.