HIV InfectionsNCT00001121
A Study to Monitor the Health of Participants in HIVNET 014 Who Become Infected With HIV-1
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in United States.
Trial summary
The purpose of this study is to evaluate the long-term consequences of HIV-1 infections that occurred in association with known, but discouraged, high-risk behaviors in persons who have received HIV candidate vaccines or placebo in HIVNET 014. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections
- How many people
- Not given
- Where
- 11 sitesUnited States
- Study dates
- Aug 1999to 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients may be eligible for this study if they:
- Become infected with HIV while participating in HIVNET 014, or if they are an HIV-positive partner (sexual or needle-sharing) of a HIVNET 014A participant.
- Are able and willing to provide written informed consent.
Who cannot join
- Patients will not be eligible for this study if they:
- Have a serious psychiatric or psychological disorder that would prevent them from completing the study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Fenway Community Health Ctr / HIVNET
Boston, Massachusetts, 02115
Univ of Illinois Chicago / Howard Brown Hlth Ctr
Chicago, Illinois, 60612
Howard Brown Health Ctr / HIVNET
Chicago, Illinois, 60657
Denver Dept of Public Health / HIVNET
Denver, Colorado, 80204
New York Univ Med Ctr
New York, New York, 10016
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, 02860
Univ of Pennsylvania / HIVNET
Philadelphia, Pennsylvania, 19104
Miriam Hosp
Providence, Rhode Island, 02906
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, 94102
Univ of Washington
Seattle, Washington, 98104
New York Blood Ctr
The Bronx, New York, 10456
About this study
Official title: Evaluation of Virologic, Immunologic, and Clinical Parameters of Participants in HIVNET 014 Who Become Infected With HIV-1
The purpose of this study is to evaluate the long-term consequences of HIV-1 infections that occurred in association with known, but discouraged, high-risk behaviors in persons who have received HIV candidate vaccines or placebo in HIVNET 014. Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS.
Patients who receive HIV vaccines are sometimes protected from HIV infection. More often, these patients become HIV-positive but experience a boost in their immune system that helps their bodies fight HIV. Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS.
Read the detailed description
There are many possible outcomes of HIV-1 infection among persons who receive experimental HIV-1 vaccines. In the best-case scenario, these vaccines may prevent infection (sterilizing immunity). However, current viral vaccines are thought to limit, but not prevent, virus replication after infection. In the latter case, it is important to document the effect of the immune response on the disease course as reflected by viral load, the evolution of the viral quasi species, and clinical symptoms over time. Understanding the evolution of the immune response in vaccinees after subsequent exposure and HIV infection will potentially result in valuable information for the subsequent design of preventive and therapeutic vaccines. This will be studied here using HIVNET 014 participants at higher risk for HIV-1 infection.
Participants discontinue HIVNET 014 vaccinations upon confirmation of HIV-1 infection and are enrolled in this study. Participants undergo clinical and laboratory examinations every 3 months for the first year of follow-up and every 6 months for at least 4 years thereafter. Additionally, HIV-infected partners of HIVNET 014A participants undergo clinical and laboratory examination at enrollment, and may be asked to donate additional specimens at a later time. Study endpoints include various virologic, immunologic, and clinical parameters, such as viral load, cellular immune response, and virus phenotype and genotype.
- Conditions
- HIV Infections
- Keywords
- Placebos, AIDS Vaccines, Follow-Up Studies, HIV Therapeutic Vaccine
- 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 posted31 Aug 2001 (estimated)
- Study startAug 1999
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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Connie Celum, Study chairSusan Buchbinder, Study chairHaynes Sheppard, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001121
- Sponsor's protocol ID
- HIVNET 014A
- Status last verified
- Jun 2003
- First submitted
- 2 Nov 1999
- Last updated
- 12 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Virologic, Immunologic, and Clinical Parameters of Participants in HIVNET 014 Who Become Infected With HIV-1
- ClinicalTrials.gov ID
- NCT00001121
- Acronym / sponsor ID
- HIVNET 014A
- Conditions
- HIV Infections
- Keywords
- Placebos, AIDS Vaccines, Follow-Up Studies, HIV Therapeutic Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 1999
- 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 evaluate the long-term consequences of HIV-1 infections that occurred in association with known, but discouraged, high-risk behaviors in persons who have received HIV candidate vaccines or placebo in HIVNET 014. Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS.
Patients who receive HIV vaccines are sometimes protected from HIV infection. More often, these patients become HIV-positive but experience a boost in their immune system that helps their bodies fight HIV. Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS.
Detailed description
There are many possible outcomes of HIV-1 infection among persons who receive experimental HIV-1 vaccines. In the best-case scenario, these vaccines may prevent infection (sterilizing immunity). However, current viral vaccines are thought to limit, but not prevent, virus replication after infection. In the latter case, it is important to document the effect of the immune response on the disease course as reflected by viral load, the evolution of the viral quasi species, and clinical symptoms over time. Understanding the evolution of the immune response in vaccinees after subsequent exposure and HIV infection will potentially result in valuable information for the subsequent design of preventive and therapeutic vaccines. This will be studied here using HIVNET 014 participants at higher risk for HIV-1 infection.
Participants discontinue HIVNET 014 vaccinations upon confirmation of HIV-1 infection and are enrolled in this study. Participants undergo clinical and laboratory examinations every 3 months for the first year of follow-up and every 6 months for at least 4 years thereafter. Additionally, HIV-infected partners of HIVNET 014A participants undergo clinical and laboratory examination at enrollment, and may be asked to donate additional specimens at a later time. Study endpoints include various virologic, immunologic, and clinical parameters, such as viral load, cellular immune response, and virus phenotype and genotype.
Study design
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Become infected with HIV while participating in HIVNET 014, or if they are an HIV-positive partner (sexual or needle-sharing) of a HIVNET 014A participant.
- Are able and willing to provide written informed consent.
Key exclusion criteria (2 listed)
- Have a serious psychiatric or psychological disorder that would prevent them from completing the study.
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 12 Sep 2008.
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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.
Connie Celum study chair
Susan Buchbinder study chair
Haynes Sheppard study chair
11 sites 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 11 sites 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 3 inclusion and 2 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 12 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
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 12 Sep 2008.