HIV InfectionsNCT00005020
Observing Patients With Early 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 purpose of this study is to monitor patients who have recently been infected with HIV in order to learn how their immune systems respond to HIV infection and to study how the virus multiplies in their bodies. Patients who have been infected with HIV recently are considered to have acute, or early, HIV infection. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Volunteers may be eligible for Cohort I of this study if they:
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Have no active infections or cancer.
- Are HIV-negative.
- Volunteers may be eligible for Cohort II of this study if they:
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Have acute or early HIV infection. The stage of HIV infection will depend on the results of certain lab tests.
- Agree not to take anti-HIV drugs the first 4 weeks of the study.
Who cannot join
- Volunteers will not be eligible for this study if they:
- Weigh less than 45 kg (99 pounds).
- Have begun anti-HIV therapy.
- Are pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study of Viral and Immune Dynamics in Subjects With Acute HIV Infection: A Study of the UCSD Acute/Early HIV Infection (AEHIV) Clinical Studies Unit
The purpose of this study is to monitor patients who have recently been infected with HIV in order to learn how their immune systems respond to HIV infection and to study how the virus multiplies in their bodies.
Patients who have been infected with HIV recently are considered to have acute, or early, HIV infection. During this period, viral load (level of HIV in the body) rises sharply to a high level at first but then decreases significantly on its own. Doctors are not sure why this decrease in viral load happens and how the body is able to accomplish this. In this study, patients with acute HIV infection will be monitored so that doctors can study their immune systems to try to learn more about this rise and fall in viral load.
Read the detailed description
Two theories offer possible explanations for the early decline of viral loads seen in acute HIV infection. The first is that CD4 target cell numbers are depleted, so the reduction in permissive target cells limits viral replication. A second is that the host develops an HIV-specific cytotoxic T lymphocyte (CTL) immune response that limits viral replication during the initial high viral titer. Consequently, enhanced clearance of HIV-infected cells results in a decline of plasma HIV RNA. This study examines the latter theory by characterizing viral and immune dynamics in the blood and lymph nodes of HIV-infected patients.
Cohort I (HIV-negative volunteers): At study entry a medical history and physical exam is performed, and volunteers complete a questionnaire. Blood samples are drawn weekly until Week 12, then at Weeks 14, 16, 20, and 24. Volunteers are followed for 24 weeks. Volunteers are offered the opportunity to participate in a lymphoid tissue substudy, which involves one to four sequential gut-associated lymphoid biopsies. Compensation for travel and for the inconvenience of study participation is provided.
Cohort II: At study entry a patient history and physical exam is performed, and volunteers complete a questionnaire. Volunteers with a rising plasma HIV RNA during the first three visits will have frequent sampling of blood and physical exams for two years. Volunteers continue to be followed thereafter once every 6 months through 5 years of study duration. Volunteers are offered the opportunity to participate in a lymphoid tissue substudy and/or the lymphoid kinetics substudy. These substudies require hospitalizations of 24 hours or less for tissue biopsies and glucose infusion. Compensation for travel and for the inconvenience of study participation is provided
- Conditions
- HIV Infections
- Keywords
- CD4 Lymphocyte Count, CD4-Positive T-Lymphocytes, Phenotype, Viral Load, Acute Infection
- 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)
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
- 10 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Susan Little, Principal investigatorDiane Havlir, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005020
- Sponsor's protocol ID
- AIEDRP AI-05-008
- Other IDs
- AEHIV 008
- Status last verified
- Dec 2004
- First submitted
- 6 Apr 2000
- Last updated
- 25 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Viral and Immune Dynamics in Subjects With Acute HIV Infection: A Study of the UCSD Acute/Early HIV Infection (AEHIV) Clinical Studies Unit
- ClinicalTrials.gov ID
- NCT00005020
- Acronym / sponsor ID
- AIEDRP AI-05-008
- Conditions
- HIV Infections
- Keywords
- CD4 Lymphocyte Count, CD4-Positive T-Lymphocytes, Phenotype, Viral Load, Acute Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- 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 monitor patients who have recently been infected with HIV in order to learn how their immune systems respond to HIV infection and to study how the virus multiplies in their bodies.
Patients who have been infected with HIV recently are considered to have acute, or early, HIV infection. During this period, viral load (level of HIV in the body) rises sharply to a high level at first but then decreases significantly on its own. Doctors are not sure why this decrease in viral load happens and how the body is able to accomplish this. In this study, patients with acute HIV infection will be monitored so that doctors can study their immune systems to try to learn more about this rise and fall in viral load.
Detailed description
Two theories offer possible explanations for the early decline of viral loads seen in acute HIV infection. The first is that CD4 target cell numbers are depleted, so the reduction in permissive target cells limits viral replication. A second is that the host develops an HIV-specific cytotoxic T lymphocyte (CTL) immune response that limits viral replication during the initial high viral titer. Consequently, enhanced clearance of HIV-infected cells results in a decline of plasma HIV RNA. This study examines the latter theory by characterizing viral and immune dynamics in the blood and lymph nodes of HIV-infected patients.
Cohort I (HIV-negative volunteers): At study entry a medical history and physical exam is performed, and volunteers complete a questionnaire. Blood samples are drawn weekly until Week 12, then at Weeks 14, 16, 20, and 24. Volunteers are followed for 24 weeks. Volunteers are offered the opportunity to participate in a lymphoid tissue substudy, which involves one to four sequential gut-associated lymphoid biopsies. Compensation for travel and for the inconvenience of study participation is provided.
Cohort II: At study entry a patient history and physical exam is performed, and volunteers complete a questionnaire. Volunteers with a rising plasma HIV RNA during the first three visits will have frequent sampling of blood and physical exams for two years. Volunteers continue to be followed thereafter once every 6 months through 5 years of study duration. Volunteers are offered the opportunity to participate in a lymphoid tissue substudy and/or the lymphoid kinetics substudy. These substudies require hospitalizations of 24 hours or less for tissue biopsies and glucose infusion. Compensation for travel and for the inconvenience of study participation is provided
Study design
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Have no active infections or cancer.
- Are HIV-negative.
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Have acute or early HIV infection. The stage of HIV infection will depend on the results of certain lab tests.
Key exclusion criteria (4 listed)
- Weigh less than 45 kg (99 pounds).
- Have begun anti-HIV therapy.
- Are pregnant or breast-feeding.
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 25 Mar 2010.
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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.
Susan Little principal investigator
Diane Havlir principal investigator
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 8 inclusion and 4 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 25 Mar 2010. 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 25 Mar 2010.