Acute HIV InfectionNCT01434706
Implementation of Nucleic Acid Amplification Testing Screening to Identify Acute and Early HIV Infection
A study testing Nucleic Acid Amplification Testing in people with Acute HIV Infection, run by University of California, San Diego at 5 sites in United States.
Trial summary
The investigators propose to study the impact of nucleic acid amplification testing (NAT) screening for acute Human Immunodeficiency Virus (HIV) and Hepatitis C (HCV) infections and Less-Sensitive Enzyme linked Immunoassay (LS-EIA) or 'detuned' testing Vironostika, Trinity Biotech BED, or Ortho-Clinical Diagnostic… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Acute HIV Infection
- What is being tested?
- Nucleic Acid Amplification Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22,607 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Sep 2010to 7 Apr 2015
- Phase
- Interventional
- 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
- Persons presenting for HIV testing to Public Health Department HIV testing site.
- Men and women >13 years of age.
- Those who are 13 or older and younger than 18 should be an emancipated minor or have consent given by their legal representative.
- Participants 18 and over must be able to provide written consent.
- Participants should be available for follow up for a period of at least 2 weeks after enrollment
Who cannot join
- Refusal to participate.
- Unable to provide informed consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Christie's Place
San Diego, California, 92101
San Diego LGBT Community Center
San Diego, California, 92103
UC San Diego Antiviral Research Center
San Diego, California, 92103
UCSD Lead the Way Storefront
San Diego, California, 92103
Family Health Centers of San Diego
San Diego, California, 92104
About this study
Official title: NAT: The Early Test Program: Implementation of NAT Screening to Identify Acute and Early HIV Infection at San Diego Public HIV Counseling and Testing Sites
The investigators propose to study the impact of nucleic acid amplification testing (NAT) screening for acute Human Immunodeficiency Virus (HIV) and Hepatitis C (HCV) infections and Less-Sensitive Enzyme linked Immunoassay (LS-EIA) or 'detuned' testing Vironostika, Trinity Biotech BED, or Ortho-Clinical Diagnostic Vistros ECi for early HIV infection in conjunction with routine rapid HIV testing at HIV counseling and testing sites and venues in the San Diego county. The overarching goal of this study is to develop and implement a system to identify, notify and engage into care those individuals with recent HIV infection in order to better define the HIV and Hepatitis C Virus (HCV) epidemics in the San Diego county and to evaluate and characterize HIV transmission dynamics within the San Diego population.
- Conditions
- Acute HIV Infection
- Being tested
- Nucleic Acid Amplification Testing
- Keywords
- HIV, acute infection, primary infection, seroconverters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nucleic Acid Amplification TestingOther
The Gen-Probe Transcription-Mediated Amplification (TMA) technology exponentially amplifies captured HIV-1 and HCV RNA in blood samples. The Gen-Probe system is available in two commercially available FDA approved products; 1) the Procleix assay is a multiplex system that is used to screen the blood supply for HIV and HCV. This assay will allow the simultaneous detection of all known HIV-1 subtypes with sensitivities designed to reduce the window period of false negative results from standard HIV antibody testing (EIA), while maintaining the ability to discriminate positive from negative specimens, even at very low copy numbers (Giachetti, Linnen et al., 2002).
| Study group | Role | What they receive |
|---|---|---|
| Nucleic Acid Amplification Testing | Other | Nucleic Acid Amplification Testing Receives: Other: Nucleic Acid Amplification Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nucleic Acid Amplification Testing
Positive detection of presence of HIV
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study start16 Sep 2010
- Primary completion7 Apr 2015
- Study completion7 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute HIV InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22,607 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Davey Smith, MD, MAS, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434706
- Sponsor's protocol ID
- 10-1414
- Status last verified
- Oct 2019
- First submitted
- 13 Sep 2011
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAT: The Early Test Program: Implementation of NAT Screening to Identify Acute and Early HIV Infection at San Diego Public HIV Counseling and Testing Sites
- ClinicalTrials.gov ID
- NCT01434706
- Acronym / sponsor ID
- 10-1414
- Conditions
- Acute HIV Infection
- Keywords
- HIV, acute infection, primary infection, seroconverters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22,607 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Centers for Disease Control and Prevention
- Study start
- 16 Sep 2010 (actual)
- Primary completion
- 7 Apr 2015 (actual)
- Study completion
- 7 Apr 2015 (actual)
- First posted
- 15 Sep 2011 (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 investigators propose to study the impact of nucleic acid amplification testing (NAT) screening for acute Human Immunodeficiency Virus (HIV) and Hepatitis C (HCV) infections and Less-Sensitive Enzyme linked Immunoassay (LS-EIA) or 'detuned' testing Vironostika, Trinity Biotech BED, or Ortho-Clinical Diagnostic Vistros ECi for early HIV infection in conjunction with routine rapid HIV testing at HIV counseling and testing sites and venues in the San Diego county. The overarching goal of this study is to develop and implement a system to identify, notify and engage into care those individuals with recent HIV infection in order to better define the HIV and Hepatitis C Virus (HCV) epidemics in the San Diego county and to evaluate and characterize HIV transmission dynamics within the San Diego population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nucleic Acid Amplification Testing | Other | Other: Nucleic Acid Amplification TestingNucleic Acid Amplification Testing |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Persons presenting for HIV testing to Public Health Department HIV testing site.
- Men and women >13 years of age.
- Those who are 13 or older and younger than 18 should be an emancipated minor or have consent given by their legal representative.
- Participants 18 and over must be able to provide written consent.
- Participants should be available for follow up for a period of at least 2 weeks after enrollment
Key exclusion criteria (2 listed)
- Refusal to participate.
- Unable to provide informed consent.
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 |
|---|---|---|
| Nucleic Acid Amplification TestingThe Gen-Probe Transcription-Mediated Amplification (TMA) technology exponentially amplifies captured HIV-1 and HCV RNA in blood samples. The Gen-Probe system is available in two commercially available FDA approved products; 1) the Procleix assay is a multiplex system that is used to screen the blood supply for HIV and HCV. This assay will allow the simultaneous detection of all known HIV-1 subtypes with sensitivities designed to reduce the window period of false negative results from standard HIV antibody testing (EIA), while maintaining the ability to discriminate positive from negative specimens, even at very low copy numbers (Giachetti, Linnen et al., 2002). | Other | Nucleic Acid Amplification Testing |
Primary outcome
Nucleic Acid Amplification Testing
Time frame: 10 minutes
Positive detection of presence of HIV
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 21 Oct 2019.
- The Early TestLink provided by the sponsor.
Related trials for Acute HIV Infection
Not yet recruitingPhase 1
A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute/Early HIV-1 Infection
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Not yet recruitingPhase 1
huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers
Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
RecruitingPhase 2
A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
Acute HIV Infection
Recruiting
Immuno-virological Evaluation of Persons Living With HIV (PLWH)
HIV-1-infection, HIV Seropositivity
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nucleic Acid Amplification Testing in people with Acute HIV Infection, run by University of California, San Diego at 5 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 5 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 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does the primary outcome measure?
Nucleic Acid Amplification Testing (time frame: 10 minutes). 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 21 Oct 2019.