HIV InfectionsNCT00296660
Acute HIV Infection Observational Study
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in 5 countries.
Trial summary
The purpose of this study is to collect data and body fluid samples from people with acute or established HIV infection and from HIV uninfected people. Data from this study will be used to better understand properties of HIV, including HIV transmission and the differences between acute and established HIV infections. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 1,300 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Jun 2006to Jun 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to 1300 with either an acute HIV-1 infection, established HIV-1 infection, or without HIV-1 infection will be enrolled. Sexual partners of those with an acute infection will also be enrolled.
Who may be able to join
- Willing to receive HIV test results
- Willing to provide updated locator information during the study
- Acute HIV infection OR sexual partner of a Group 1 participant with acute HIV infection
- Established HIV infection (positive HIV antibody test and positive HIV Western blot)
- HIV uninfected
Who cannot join
- Plan to relocate out of the area during the study or have a job or other obligations that may require long absences from the area
- Currently on antiretroviral therapy. Women who previously took antiretroviral therapy for the prevention of mother-to-child transmission of HIV are not excluded.
- Any other condition that, in the opinion of the investigator, may interfere with the study
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
South Africa3 sites
CAPRISA eThekwini CHAVI CRS
Durban, KwaZulu-Natal, 4001
Univ. of Witwatersrand, Chris Hani Baragwanath Hosp., Reproductive Health Research Unit CHAVI CRS
Johannesburg, Gauteng, 2001
Aurum Institute for Health Research CHAVI CRS
Klerksdorp, 2571
United States2 sites
UNC School of Medicine, Div. of Infectious Diseases CHAVI CRS
Chapel Hill, North Carolina, 27599-7005
Duke Univ. Med. Ctr., Infectious Diseases Clinic CHAVI CRS
Durham, North Carolina, 27710
Malawi2 sites
Queen Elizabeth Hosp., Malawi College of Medicine-Johns Hopkins Research Project CHAVI CRS
Blantyre
Kamuzu Central Hosp. CHAVI CRS
Lilongwe
Uganda1 site
Uganda Virus Research Institute, MRC/UVRI Uganda Research Unit on AIDS CHAVI CRS
Entebbe
About this study
Official title: Acute HIV-1 Infection Prospective Cohort Study
The purpose of this study is to collect data and body fluid samples from people with acute or established HIV infection and from HIV uninfected people. Data from this study will be used to better understand properties of HIV, including HIV transmission and the differences between acute and established HIV infections.
Read the detailed description
Previous studies have identified strategies for the large-scale identification of acute HIV infections. One system using such strategies has already been implemented in North Carolina, and this system will be used in this study run by the Center of HIV/AIDS Vaccine Immunology (CHAVI). This study will collect data on the mechanism of HIV transmission and the genetic, biologic, antigenic, and structural characteristics of the virus. The study will enroll HIV infected people with acute HIV infection and their sexual partners, people with established HIV infection, and HIV uninfected people.
This study will last 96 weeks. Group 1 participants will be people with acute HIV infection. These participants will have 15 study visits; some visits will include a physical exam and medical history. Group 1 will also be asked to complete a sexual behavioral assessment at study entry and every 12 weeks thereafter. Group 2 participants will be people with established HIV infection. Group 3 participants will be HIV uninfected people. Groups 2 and 3 will have 10 study visits; some visits will include a physical exam and medical history. Groups 2 and 3 will also be asked to complete a sexual behavioral assessment at study entry, every 12 weeks until Week 72, and Week 96. Group 3 will undergo HIV testing at each visit and will receive pre- and post-test counseling.
At each visit, participants will undergo HIV safe sex counseling and will update their locator information. Blood, genital secretion, and breast milk collection will also occur at each visit.
- Conditions
- HIV Infections
- Keywords
- Acute Infection
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Proven acute HIV-1 infection | |
| 1A | Sexual partners of members of Group 1 | |
| 2 | Established HIV-infection | |
| 3 | HIV-1 uninfected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of acute HIV infection
Measured: Throughout study
Characteristics of transmitted virus in acute HIV infection
Measured: Throughout study
Immune responses contributing to viral control and/or protection against HIV infection
Measured: Throughout study
Genetic factors contributing to early virus control and/or protection from HIV infection
Measured: Throughout study
Clinical, laboratory, and behavioral characteristics of individuals at diverse sites with acute HIV infection and their sexual partners, and appropriate controls
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- 1,300 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Myron S. Cohen, MD, Study chair, Medicine, Microbiology, and Immunology and Public Health, Division of Infectious Diseases, University of North Carolina Center for Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296660
- Sponsor's protocol ID
- CHAVI 001
- Status last verified
- Nov 2013
- First submitted
- 24 Feb 2006
- Last updated
- 19 Nov 2013
- Results posted
- No
Publications
Lindback S, Thorstensson R, Karlsson AC, von Sydow M, Flamholc L, Blaxhult A, Sonnerborg A, Biberfeld G, Gaines H. Diagnosis of primary HIV-1 infection and duration of follow-up after HIV exposure. Karolinska Institute Primary HIV Infection Study Group. AIDS. 2000 Oct 20;14(15):2333-9. doi: 10.1097/00002030-200010200-00014.
PubMed 11089621Pilcher CD, Eron JJ Jr, Galvin S, Gay C, Cohen MS. Acute HIV revisited: new opportunities for treatment and prevention. J Clin Invest. 2004 Apr;113(7):937-45. doi: 10.1172/JCI21540.
PubMed 15057296Pilcher CD, Fiscus SA, Nguyen TQ, Foust E, Wolf L, Williams D, Ashby R, O'Dowd JO, McPherson JT, Stalzer B, Hightow L, Miller WC, Eron JJ Jr, Cohen MS, Leone PA. Detection of acute infections during HIV testing in North Carolina. N Engl J Med. 2005 May 5;352(18):1873-83. doi: 10.1056/NEJMoa042291.
PubMed 15872202Pilcher CD, McPherson JT, Leone PA, Smurzynski M, Owen-O'Dowd J, Peace-Brewer AL, Harris J, Hicks CB, Eron JJ Jr, Fiscus SA. Real-time, universal screening for acute HIV infection in a routine HIV counseling and testing population. JAMA. 2002 Jul 10;288(2):216-21. doi: 10.1001/jama.288.2.216.
PubMed 12095386Soogoor M, Daar ES. Primary human immunodeficiency virus type 1 infection. Curr HIV/AIDS Rep. 2005 Jun;2(2):55-60. doi: 10.1007/s11904-005-0019-1.
PubMed 16091249
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute HIV-1 Infection Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT00296660
- Acronym / sponsor ID
- CHAVI 001
- Conditions
- HIV Infections
- Keywords
- Acute Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jun 2006
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Feb 2006 (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 collect data and body fluid samples from people with acute or established HIV infection and from HIV uninfected people. Data from this study will be used to better understand properties of HIV, including HIV transmission and the differences between acute and established HIV infections.
Detailed description
Previous studies have identified strategies for the large-scale identification of acute HIV infections. One system using such strategies has already been implemented in North Carolina, and this system will be used in this study run by the Center of HIV/AIDS Vaccine Immunology (CHAVI). This study will collect data on the mechanism of HIV transmission and the genetic, biologic, antigenic, and structural characteristics of the virus. The study will enroll HIV infected people with acute HIV infection and their sexual partners, people with established HIV infection, and HIV uninfected people.
This study will last 96 weeks. Group 1 participants will be people with acute HIV infection. These participants will have 15 study visits; some visits will include a physical exam and medical history. Group 1 will also be asked to complete a sexual behavioral assessment at study entry and every 12 weeks thereafter. Group 2 participants will be people with established HIV infection. Group 3 participants will be HIV uninfected people. Groups 2 and 3 will have 10 study visits; some visits will include a physical exam and medical history. Groups 2 and 3 will also be asked to complete a sexual behavioral assessment at study entry, every 12 weeks until Week 72, and Week 96. Group 3 will undergo HIV testing at each visit and will receive pre- and post-test counseling.
At each visit, participants will undergo HIV safe sex counseling and will update their locator information. Blood, genital secretion, and breast milk collection will also occur at each visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Proven acute HIV-1 infection |
| 1A | – | –Sexual partners of members of Group 1 |
| 2 | – | –Established HIV-infection |
| 3 | – | –HIV-1 uninfected |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 1300 with either an acute HIV-1 infection, established HIV-1 infection, or without HIV-1 infection will be enrolled. Sexual partners of those with an acute infection will also be enrolled.
Key inclusion criteria (5 listed)
- Willing to receive HIV test results
- Willing to provide updated locator information during the study
- Acute HIV infection OR sexual partner of a Group 1 participant with acute HIV infection
- Established HIV infection (positive HIV antibody test and positive HIV Western blot)
- HIV uninfected
Key exclusion criteria (3 listed)
- Plan to relocate out of the area during the study or have a job or other obligations that may require long absences from the area
- Currently on antiretroviral therapy. Women who previously took antiretroviral therapy for the prevention of mother-to-child transmission of HIV are not excluded.
- Any other condition that, in the opinion of the investigator, may interfere with the study
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
Prevalence of acute HIV infection
Time frame: Throughout study
Characteristics of transmitted virus in acute HIV infection
Time frame: Throughout study
Immune responses contributing to viral control and/or protection against HIV infection
Time frame: Throughout study
Genetic factors contributing to early virus control and/or protection from HIV infection
Time frame: Throughout study
Clinical, laboratory, and behavioral characteristics of individuals at diverse sites with acute HIV infection and their sexual partners, and appropriate controls
Time frame: Throughout study
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 19 Nov 2013.
- Background: PubMed 11089621Lindback S, Thorstensson R, Karlsson AC, von Sydow M, Flamholc L, Blaxhult A, Sonnerborg A, Biberfeld G, Gaines H. Diagnosis of primary HIV-1 infection and duration of follow-up after HIV exposure. Karolinska Institute Primary HIV Infection Study Group. AIDS. 2000 Oct 20;14(15):2333-9. doi: 10.1097/00002030-200010200-00014.
- Background: PubMed 15057296Pilcher CD, Eron JJ Jr, Galvin S, Gay C, Cohen MS. Acute HIV revisited: new opportunities for treatment and prevention. J Clin Invest. 2004 Apr;113(7):937-45. doi: 10.1172/JCI21540.
- Background: PubMed 15872202Pilcher CD, Fiscus SA, Nguyen TQ, Foust E, Wolf L, Williams D, Ashby R, O'Dowd JO, McPherson JT, Stalzer B, Hightow L, Miller WC, Eron JJ Jr, Cohen MS, Leone PA. Detection of acute infections during HIV testing in North Carolina. N Engl J Med. 2005 May 5;352(18):1873-83. doi: 10.1056/NEJMoa042291.
- Background: PubMed 12095386Pilcher CD, McPherson JT, Leone PA, Smurzynski M, Owen-O'Dowd J, Peace-Brewer AL, Harris J, Hicks CB, Eron JJ Jr, Fiscus SA. Real-time, universal screening for acute HIV infection in a routine HIV counseling and testing population. JAMA. 2002 Jul 10;288(2):216-21. doi: 10.1001/jama.288.2.216.
- Background: PubMed 16091249Soogoor M, Daar ES. Primary human immunodeficiency virus type 1 infection. Curr HIV/AIDS Rep. 2005 Jun;2(2):55-60. doi: 10.1007/s11904-005-0019-1.
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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.
Myron S. Cohen, MD study chair
Medicine, Microbiology, and Immunology and Public Health, Division of Infectious Diseases, University of North Carolina Center for Infectious Diseases
9 sites in 5 countries: 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 9 sites in 5 countries.
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 3 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 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Africa, United States, Malawi, Tanzania, Uganda. 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?
Prevalence of acute HIV infection (time frame: Throughout study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00296660, which also lists 5 linked publications.
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 19 Nov 2013.