Acute HIV Infection Observational Study

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 1300

Contacts and Locations

Study Locations

• Malawi
  • Blantyre, Malawi
    • Queen Elizabeth Hosp., Malawi College of Medicine-Johns Hopkins Research Project CHAVI CRS
  • Lilongwe, Malawi
    • Kamuzu Central Hosp. CHAVI CRS
• South Africa
  • Klerksdorp, South Africa, 2571
    • Aurum Institute for Health Research CHAVI CRS
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2001
      • Univ. of Witwatersrand, Chris Hani Baragwanath Hosp., Reproductive Health Research Unit CHAVI CRS
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4001
      • CAPRISA eThekwini CHAVI CRS
• Tanzania
  • Moshi, Tanzania
    • Kilimanjaro Christian Med. Ctr. CHAVI CRS
• Uganda
  • Entebbe, Uganda
    • Uganda Virus Research Institute, MRC/UVRI Uganda Research Unit on AIDS CHAVI CRS
• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7005
      • UNC School of Medicine, Div. of Infectious Diseases CHAVI CRS
    • Durham, North Carolina, United States, 27710
      • Duke Univ. Med. Ctr., Infectious Diseases Clinic CHAVI CRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria for All Participants:

• Willing to receive HIV test results
• Willing to provide updated locator information during the study

Inclusion Criteria for Group 1:

• Acute HIV infection OR sexual partner of a Group 1 participant with acute HIV infection

Inclusion Criteria for Group 2:

• Established HIV infection (positive HIV antibody test and positive HIV Western blot)

Inclusion Criteria for Group 3:

• HIV uninfected

Exclusion Criteria for All Participants:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
1; Proven acute HIV-1 infection
1A; Sexual partners of members of Group 1
2; Established HIV-infection
3; HIV-1 uninfected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of acute HIV infection	Throughout study
Characteristics of transmitted virus in acute HIV infection	Throughout study
Immune responses contributing to viral control and/or protection against HIV infection	Throughout study
Genetic factors contributing to early virus control and/or protection from HIV infection	Throughout study
Clinical, laboratory, and behavioral characteristics of individuals at diverse sites with acute HIV infection and their sexual partners, and appropriate controls	Throughout study

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: Myron S. Cohen, MD, Medicine, Microbiology, and Immunology and Public Health, Division of Infectious Diseases, University of North Carolina Center for Infectious Diseases

Publications and helpful links

General Publications

• Pilcher 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. Erratum In: J Clin Invest. 2006 Dec;116(12):3292.
• Pilcher 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.
• 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.
• Pilcher 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.
• Soogoor 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: February 24, 2006
• First Submitted That Met QC Criteria: February 24, 2006
• First Posted (Estimate): February 27, 2006

Study Record Updates

• Last Update Posted (Estimate): November 19, 2013
• Last Update Submitted That Met QC Criteria: November 18, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Acute Infection
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: CHAVI 001