HIV InfectionsNCT00219947
Viral and Host Factors in the Transmission and Pathogenesis of HIV
An observational study of HIV Infections, run by Rockefeller University at 2 sites in United States.
Trial summary
To study the collection of blood from individuals known to be at high risk for HIV-infection or who have been recently infected with HIV. The data collected are used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment Guidelines. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- blood draw
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2000to Mar 2019
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects are either referred by primary health care providers, self-referred, or may be seeking enrollment in other ADARC clinical trials in the NYC area.
Who may be able to join
- recently infected with HIV-1 HIV-1 negative, and at high risk for infection
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Aaron Diamond AIDS Research Center (ADARC)
New York, New York, 10016
Rockefeller University Hospital
New York, New York, 10021
About this study
To study the collection of blood from individuals known to be at high risk for HIV-infection or who have been recently infected with HIV.
The data collected are used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment Guidelines.
Read the detailed description
This phlebotomy protocol permits the collection of blood from individuals known to be at high risk for HIV-infection or who have been recently infected with HIV.
Participants will have from 10 to 60 ml (approximately 1 to 4 tablespoons) of blood drawn for one or all of the following tests:
- T cell subset enumeration
- Serologic reactivity with HIV antigens
- Viral load assays by bDNA, PCR, or RT-PCR
- Routine Laboratory assessments (chemistries, liver function tests, hepatitis serology, RPR)
- HIV-1 Resistance Testing
These data are used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment Guidelines
- Conditions
- HIV Infections
- Being tested
- blood draw
- Keywords
- HIV Infection, Acute HIV Infection, Primary HIV Infection, Acute Seroconversion Syndrome
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawOther
- T cell subset enumeration
- Serologic reactivity with HIV antigens
- Viral load assays by bDNA, PCR, or RT-PCR
- Routine Laboratory assessments (chemistries, liver function tests, hepatitis serology, RPR)
- HIV-1 Resistance Testing
| Study group | Role | What they receive |
|---|---|---|
| high risk | Blood draw from individuals known to be or at high risk for HIV-infection Receives: Other: blood draw | |
| diagnosed | Blood draw f rom individuals diagnosed with HIV infection Receives: Other: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants are tested for HIV-1 RNA levels, the presence of antibodies to HIV antigens, and T cell subsets
Measured: first visit
Secondary outcomes (1)
Data will be used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment
Measured: first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2000
- Primary completionMar 2019
- Study completionMar 2019
Why it stopped: Blood drawing protocol for RUH/ADARC. ADARC ceasing operations at RUH
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin M Markowitz, MD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219947
- Sponsor's protocol ID
- MMA-448
- Status last verified
- Apr 2019
- First submitted
- 20 Sep 2005
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viral and Host Factors in the Transmission and Pathogenesis of HIV
- ClinicalTrials.gov ID
- NCT00219947
- Acronym / sponsor ID
- MMA-448
- Conditions
- HIV Infections
- Keywords
- HIV Infection, Acute HIV Infection, Primary HIV Infection, Acute Seroconversion Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Blood drawing protocol for RUH/ADARC. ADARC ceasing operations at RUH
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Jul 2000
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 22 Sep 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.
To study the collection of blood from individuals known to be at high risk for HIV-infection or who have been recently infected with HIV.
The data collected are used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment Guidelines.
Detailed description
This phlebotomy protocol permits the collection of blood from individuals known to be at high risk for HIV-infection or who have been recently infected with HIV.
Participants will have from 10 to 60 ml (approximately 1 to 4 tablespoons) of blood drawn for one or all of the following tests:
- T cell subset enumeration
- Serologic reactivity with HIV antigens
- Viral load assays by bDNA, PCR, or RT-PCR
- Routine Laboratory assessments (chemistries, liver function tests, hepatitis serology, RPR)
- HIV-1 Resistance Testing
These data are used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment Guidelines
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high risk | – | Other: blood drawBlood draw from individuals known to be or at high risk for HIV-infection |
| diagnosed | – | Other: blood drawBlood draw f rom individuals diagnosed with HIV infection |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects are either referred by primary health care providers, self-referred, or may be seeking enrollment in other ADARC clinical trials in the NYC area.
Key inclusion criteria (1 listed)
- recently infected with HIV-1 HIV-1 negative, and at high risk for infection
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| blood draw* T cell subset enumeration * Serologic reactivity with HIV antigens * Viral load assays by bDNA, PCR, or RT-PCR * Routine Laboratory assessments (chemistries, liver function tests, hepatitis serology, RPR) * HIV-1 Resistance Testing | Other | diagnosed, high risk |
Primary outcome
Participants are tested for HIV-1 RNA levels, the presence of antibodies to HIV antigens, and T cell subsets
Time frame: first visit
1 secondary outcome
Data will be used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment
Time frame: first visit
Results and safety
The study was stopped early (reason given: Blood drawing protocol for RUH/ADARC. ADARC ceasing operations at RUH). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- The Aaron Diamond AIDS Research CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Martin M Markowitz, MD principal investigator
Rockefeller University
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 Rockefeller University 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 1 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: stopped early, as of the sponsor's last update on 10 Apr 2019. 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 was stopped early (reason given: Blood drawing protocol for RUH/ADARC. ADARC ceasing operations at RUH). Results are not available in the source record.
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.
What does the primary outcome measure?
Participants are tested for HIV-1 RNA levels, the presence of antibodies to HIV antigens, and T cell subsets (time frame: first visit). It is what the study was designed to measure, not a finding.
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 10 Apr 2019.