Acute HIV Infection Observational Study

HIV Infections Clinical Trial

Official title:

Acute HIV-1 Infection Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296660
• Other study ID #: CHAVI 001
• Status: Completed
• Phase: N/A
• First received: February 24, 2006
• Last updated: November 18, 2013
• Start date: June 2006
• Est. completion date: June 2013

Study information

• Verified date: November 2013
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Malawi,  South Africa,  Tanzania,  Uganda, 

References & Publications (5)

Lindbäck S, Thorstensson R, Karlsson AC, von Sydow M, Flamholc L, Blaxhult A, Sönnerborg 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. — View Citation

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. Review. Erratum in: J Clin Invest. 2006 Dec;116(12):3292. — View Citation

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. — View Citation

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. — View Citation

Soogoor M, Daar ES. Primary human immunodeficiency virus type 1 infection. Curr HIV/AIDS Rep. 2005 Jun;2(2):55-60. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of acute HIV infection		Throughout study	No
Primary	Characteristics of transmitted virus in acute HIV infection		Throughout study	No
Primary	Immune responses contributing to viral control and/or protection against HIV infection		Throughout study	No
Primary	Genetic factors contributing to early virus control and/or protection from HIV infection		Throughout study	No
Primary	Clinical, laboratory, and behavioral characteristics of individuals at diverse sites with acute HIV infection and their sexual partners, and appropriate controls		Throughout study	No

External Links

•   Haga clic aquí para ver información sobre este ensayo clínico en español