HIV InfectionNCT00051519
Screening HIV-Infected Patients for Vaccine Studies
An observational study of HIV Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This screening study will evaluate potential study volunteers with HIV infection to see if they are suitable candidates for trials of experimental vaccines against HIV (therapeutic), and against other infections (preventive). Preventive vaccines against other infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2003to 1 Dec 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- HIV-infected, confirmed by ELISA and Western blot
- Willing to participate for the planned duration of the study (6 months or longer)
- Able and willing to give informed consent
- Agree to have blood stored for future studies related to HIV, the immune system, vaccine response and/or other medical conditions
Who cannot join
- Women who are known to be pregnant or breast feeding
- Clinically significant medical history, physical examination or laboratory test results that preclude participation in a clinical trial.
- A condition requiring medication that affects the immune response to a vaccine such as oral and parenteral corticosteroids, hydroxyurea, interleukin-2 or other immune modulators.
- A condition in which repeated blood draws or injections poses more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access.
- A condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being
- A condition in which signs or symptoms could be confused with reactions to vaccine
- Active participation in other experimental treatment studies
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Screening HIV-Infected Subjects for Vaccine Research Studies
This screening study will evaluate potential study volunteers with HIV infection to see if they are suitable candidates for trials of experimental vaccines against HIV (therapeutic), and against other infections (preventive).
- Preventive vaccines against other infections. Preventive vaccines prevent a person from getting a disease. Preventive vaccines have been developed for many diseases, including, for example, whooping cough, measles, mumps, influenza, and hepatitis B. Some preventive vaccines may also prevent a disease from taking hold if given immediately after infection, such as vaccines for rabies, smallpox and hepatitis.
- Therapeutic vaccines against HIV. Therapeutic vaccines are intended to treat someone who has already been infected, with the goal of controlling the disease or preventing it from causing severe illness. As yet, there are no therapeutic vaccines for any diseases.
- Vaccines against other infections. Vaccines to prevent other infections besides HIV may need to be tested separately in people with HIV infection because the immune system works differently when HIV infection is present.
Read more
HIV-infected patients 18 years of age or older may be eligible for this screening study. Women who are pregnant or breast feeding may not participate.
Participants will be screened with the following:
- A health history, including questions about sexual activity and drug use;
- Physical examination, including blood and urine tests;
- HIV testing to confirm HIV infection;
- Pregnancy test for premenopausal women;
- PPD test for tuberculosis for those who have not been tested in the previous 6 months.
Candidates who meet the requirements for investigational vaccine studies will be invited to participate in a study. Those who do not begin a study within 1 month of the screening tests may need to repeat some tests for continued consideration. In addition, some studies require repeated measures of CD4 counts and viral load over a period of a few months.
Read the detailed description
Study Design: The purpose of this protocol is to screen potential study volunteers with HIV infection to determine if they are suitable candidates for vaccine trials. Screening will be primarily for HIV vaccine trials, but may also be for screening HIV-infected adults to participate in trials of other kinds of vaccine studies that will be enrolling HIV-infected subjects. All work will be conducted at the National Institutes of Health. HIV-infected volunteers will be recruited and screened. This protocol will be used to determine if the volunteers meet eligibility requirements for participation in trials of vaccines in HIV-infected subjects.
Subjects: Approximately 1,000 adults with HIV infection.
Study Plan: Subjects are evaluated for eligibility to participate in a vaccine trial and receive counseling on HIV-related issues. Women receive counseling on avoidance of pregnancy during a clinical trial. If it is determined that the volunteer might be eligible for a vaccine trial, additional information about trial options will be provided by telephone, mail and/or visits with a study coordinator.
Study Duration: Approximately six months for each subject.
Study Evaluations: Evaluations usually include history and physical examinations and CBC, differential, platelets, PT/PTT, chemistry panel, urinalysis, pregnancy test for women of reproductive potential, hepatitis B surface antigen, hepatitis C antibody, RPR, ELISA and Western blot for HIV, anti-dsDNA, quantitative immunoglobulins, adenovirus serology and T cell subsets (CD4/CD8). However, only those evaluations needed to determine eligibility for a particular vaccine study will be completed. Blood will also be collected for storage. If needed for eligibility in a particular vaccine study, a PPD will be administered unless subject has documentation of a negative PPD within six months prior to enrollment. In addition, other standard clinical evaluations may be done if needed to determine eligibility for a particular vaccine study.
- Conditions
- HIV Infection
- Keywords
- HIV, AIDS, Vaccine, HIV-positive, Therapy
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, HIV Seropositivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2003 (estimated)
- Study start9 Jan 2003
- Primary completion1 Dec 2007
- Study completion1 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies 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
- 1,000 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051519
- Sponsor's protocol ID
- 030079
- Other IDs
- 03-I-0079
- Status last verified
- 25 Jun 2009
- First submitted
- 10 Jan 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening HIV-Infected Subjects for Vaccine Research Studies
- ClinicalTrials.gov ID
- NCT00051519
- Acronym / sponsor ID
- 030079
- Conditions
- HIV Infection
- Keywords
- HIV, AIDS, Vaccine, HIV-positive, Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 9 Jan 2003
- Primary completion
- 1 Dec 2007 (actual)
- Study completion
- 1 Dec 2007 (actual)
- First posted
- 13 Jan 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.
This screening study will evaluate potential study volunteers with HIV infection to see if they are suitable candidates for trials of experimental vaccines against HIV (therapeutic), and against other infections (preventive).
- Preventive vaccines against other infections. Preventive vaccines prevent a person from getting a disease. Preventive vaccines have been developed for many diseases, including, for example, whooping cough, measles, mumps, influenza, and hepatitis B. Some preventive vaccines may also prevent a disease from taking hold if given immediately after infection, such as vaccines for rabies, smallpox and hepatitis.
- Therapeutic vaccines against HIV. Therapeutic vaccines are intended to treat someone who has already been infected, with the goal of controlling the disease or preventing it from causing severe illness. As yet, there are no therapeutic vaccines for any diseases.
- Vaccines against other infections. Vaccines to prevent other infections besides HIV may need to be tested separately in people with HIV infection because the immune system works differently when HIV infection is present.
HIV-infected patients 18 years of age or older may be eligible for this screening study. Women who are pregnant or breast feeding may not participate.
Participants will be screened with the following:
- A health history, including questions about sexual activity and drug use;
- Physical examination, including blood and urine tests;
- HIV testing to confirm HIV infection;
- Pregnancy test for premenopausal women;
- PPD test for tuberculosis for those who have not been tested in the previous 6 months.
Candidates who meet the requirements for investigational vaccine studies will be invited to participate in a study. Those who do not begin a study within 1 month of the screening tests may need to repeat some tests for continued consideration. In addition, some studies require repeated measures of CD4 counts and viral load over a period of a few months.
Detailed description
Study Design: The purpose of this protocol is to screen potential study volunteers with HIV infection to determine if they are suitable candidates for vaccine trials. Screening will be primarily for HIV vaccine trials, but may also be for screening HIV-infected adults to participate in trials of other kinds of vaccine studies that will be enrolling HIV-infected subjects. All work will be conducted at the National Institutes of Health. HIV-infected volunteers will be recruited and screened. This protocol will be used to determine if the volunteers meet eligibility requirements for participation in trials of vaccines in HIV-infected subjects.
Subjects: Approximately 1,000 adults with HIV infection.
Study Plan: Subjects are evaluated for eligibility to participate in a vaccine trial and receive counseling on HIV-related issues. Women receive counseling on avoidance of pregnancy during a clinical trial. If it is determined that the volunteer might be eligible for a vaccine trial, additional information about trial options will be provided by telephone, mail and/or visits with a study coordinator.
Study Duration: Approximately six months for each subject.
Study Evaluations: Evaluations usually include history and physical examinations and CBC, differential, platelets, PT/PTT, chemistry panel, urinalysis, pregnancy test for women of reproductive potential, hepatitis B surface antigen, hepatitis C antibody, RPR, ELISA and Western blot for HIV, anti-dsDNA, quantitative immunoglobulins, adenovirus serology and T cell subsets (CD4/CD8). However, only those evaluations needed to determine eligibility for a particular vaccine study will be completed. Blood will also be collected for storage. If needed for eligibility in a particular vaccine study, a PPD will be administered unless subject has documentation of a negative PPD within six months prior to enrollment. In addition, other standard clinical evaluations may be done if needed to determine eligibility for a particular vaccine study.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- HIV-infected, confirmed by ELISA and Western blot
- Willing to participate for the planned duration of the study (6 months or longer)
- Able and willing to give informed consent
- Agree to have blood stored for future studies related to HIV, the immune system, vaccine response and/or other medical conditions
Key exclusion criteria (7 listed)
- Women who are known to be pregnant or breast feeding
- Clinically significant medical history, physical examination or laboratory test results that preclude participation in a clinical trial.
- A condition requiring medication that affects the immune response to a vaccine such as oral and parenteral corticosteroids, hydroxyurea, interleukin-2 or other immune modulators.
- A condition in which repeated blood draws or injections poses more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access.
- A condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being
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 2 Jul 2017.
Related trials for HIV Infection
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infection, 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 7 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 2 Jul 2017. 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?
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 2 Jul 2017.