HIV InfectionsNCT00103961
An Observational Study of People Who Have Recently Been Infected With HIV
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
This is a long-term follow-up study of people who are identified during acute or recent HIV infection and are being followed at clinical research sites associated with the Acute HIV Infection and Early Disease Research Program (AIEDRP). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2004to Dec 2014
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Treatment-naive and treatment-experienced HIV-infected adults
Who may be able to join
- Documented acute or recent HIV infection as defined in the study protocol
- Willing to be followed longitudinally by this study
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham & Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Primary HIV & Early Disease Research: American Cohort (PHAEDRA) AIEDRP
This is a long-term follow-up study of people who are identified during acute or recent HIV infection and are being followed at clinical research sites associated with the Acute HIV Infection and Early Disease Research Program (AIEDRP). The purpose of this study is to collect data on the immunological and virologic responses that occur early in the course of HIV infection in treatment-naive and treatment-experienced HIV infected adults.
Study hypothesis: This study will examine the immunological responses that occur early in the course of HIV infection in treated and untreated individuals. The long-term follow-up of these subjects will help identify host immunological and genetic factors along with therapeutic strategies associated with control of viremia and delayed disease progression. In addition, this cohort will provide the recruiting mechanism to support future trials of therapy to restore immune function. Furthermore, this cohort will provide a population suitable to monitoring changing patterns in the transmission of drug resistant viral strains while also evaluating ongoing behavioral risk factors associated with HIV transmission.
Read the detailed description
This study will collect data on the immunological and virologic responses that occur early in the course of HIV infection in treated and untreated HIV infected adults to identify host immunological, virological, and therapeutic factors that influence disease progression. This study will also monitor changing patterns in the transmission of drug-resistant viral strains and evaluate ongoing behavioral risk factors associated with HIV infection.
Participants in this study will be followed for up to 10 years. During the first year of participation, study visits will occur approximately every 4 weeks for the first 12 weeks, then every 12 weeks thereafter, with a minimum of 8 study visits during the first year. Participants will be asked to complete a behavioral questionnaire at Week 8. After the first year of participation, there will be 4 visits per year. Blood collection and vital sign measurement will occur at each study visit.
Participants enrolled in this study are strongly encouraged to also enroll in the AIEDRP CORE01 study.
- Conditions
- HIV Infections
- Being tested
- Questionnaire
- Keywords
- Acute Infection, HIV, AIDS, Acute HIV, Early HIV
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
A behavioral questionnaire will occur at Week 8
| Study group | Role | What they receive |
|---|---|---|
| 1 | Treatment-naive and treatment-experienced HIV-infected adults Receives: Behavioral: Questionnaire |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2005 (estimated)
- Study startJan 2004
- Primary completionOct 2007
- Study completionDec 2014
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Eric Rosenberg, MD, Principal investigator, Partners Healthcare, Massachusetts General HospitalBruce D. Walker, MD, Principal investigator, Partners Healthcare, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103961
- Sponsor's protocol ID
- 5U01AI052403
- Other IDs
- 2003-P-001991, 5U01AI052403
- Status last verified
- Sep 2008
- First submitted
- 17 Feb 2005
- Last updated
- 28 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary HIV & Early Disease Research: American Cohort (PHAEDRA) AIEDRP
- ClinicalTrials.gov ID
- NCT00103961
- Acronym / sponsor ID
- 5U01AI052403
- Conditions
- HIV Infections
- Keywords
- Acute Infection, HIV, AIDS, Acute HIV, Early HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jan 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Feb 2005 (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 is a long-term follow-up study of people who are identified during acute or recent HIV infection and are being followed at clinical research sites associated with the Acute HIV Infection and Early Disease Research Program (AIEDRP). The purpose of this study is to collect data on the immunological and virologic responses that occur early in the course of HIV infection in treatment-naive and treatment-experienced HIV infected adults.
Study hypothesis: This study will examine the immunological responses that occur early in the course of HIV infection in treated and untreated individuals. The long-term follow-up of these subjects will help identify host immunological and genetic factors along with therapeutic strategies associated with control of viremia and delayed disease progression. In addition, this cohort will provide the recruiting mechanism to support future trials of therapy to restore immune function. Furthermore, this cohort will provide a population suitable to monitoring changing patterns in the transmission of drug resistant viral strains while also evaluating ongoing behavioral risk factors associated with HIV transmission.
Detailed description
This study will collect data on the immunological and virologic responses that occur early in the course of HIV infection in treated and untreated HIV infected adults to identify host immunological, virological, and therapeutic factors that influence disease progression. This study will also monitor changing patterns in the transmission of drug-resistant viral strains and evaluate ongoing behavioral risk factors associated with HIV infection.
Participants in this study will be followed for up to 10 years. During the first year of participation, study visits will occur approximately every 4 weeks for the first 12 weeks, then every 12 weeks thereafter, with a minimum of 8 study visits during the first year. Participants will be asked to complete a behavioral questionnaire at Week 8. After the first year of participation, there will be 4 visits per year. Blood collection and vital sign measurement will occur at each study visit.
Participants enrolled in this study are strongly encouraged to also enroll in the AIEDRP CORE01 study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: QuestionnaireTreatment-naive and treatment-experienced HIV-infected adults |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Treatment-naive and treatment-experienced HIV-infected adults
Key inclusion criteria (2 listed)
- Documented acute or recent HIV infection as defined in the study protocol
- Willing to be followed longitudinally by this study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireA behavioral questionnaire will occur at Week 8 | Behavioural | 1 |
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 28 Nov 2018.
- Click here for more information on AIEDRP CORE01Link provided by the sponsor.
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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.
Eric Rosenberg, MD principal investigator
Partners Healthcare, Massachusetts General Hospital
Bruce D. Walker, MD principal investigator
Partners Healthcare, Massachusetts General Hospital
2 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 2 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 2 inclusion and 0 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 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 28 Nov 2018.