A Study of Patients Who Develop HIV Infection After Enrolling in HIV Vaccine Trials or HIV Vaccine Preparedness Trials

HIV Infections Clinical Trial

Official title:

A Multi-Site Evaluation of Virologic, Immunologic, and Clinical Natural History of Participants Enrolled in Phase I and Phase II HIV-1 Vaccine Protocols or HIV-1 Vaccine Preparedness Cohorts Who Develop HIV-1 Infection Subsequent to Trial Enrollment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029913
• Other study ID #: HVTN 403
• Secondary ID: 5U01AI068614
• Status: Completed
• Phase: N/A
• First received: January 24, 2002
• Last updated: August 31, 2010
• Start date: April 2002
• Est. completion date: July 2009

Study information

• Verified date: August 2010
• Source: HIV Vaccine Trials Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

Despite risk reduction counseling, some individuals in HIV vaccine trials or vaccine preparedness studies may engage in risk behavior that results in HIV infection. The purpose of the HVTN 403 study is to find out more about how persons respond to HIV infection if they have received an experimental HIV-1 vaccine before they became HIV infected.

Some people in HVTN 403 received an experimental HIV vaccine as a participant in a clinical trial before getting infected with HIV. Other people in this study were in a vaccine preparedness study when they got infected with HIV. None of these individuals became infected with HIV as result of their participation in an HIV vaccine or vaccine preparedness study. HVTN 403 will compare immune responses between those who previously received an experimental HIV vaccine and those who did not. Information learned from this study may be important in guiding future developments of new HIV vaccines and other treatments for HIV and AIDS.

Description:

It is important to study persons vaccinated with candidate HIV-1 vaccines who have become HIV-1 infected for the following reasons. First, if transient HIV-1 infection is detected and then is effectively suppressed or cleared, it will be important to document the antigenic relationship between the breakthrough virus and the vaccine epitopes to attempt to answer questions about the specificity and breadth of the immune response and the determinants of immunity. A second reason is to gain a better understanding of vaccine-induced responses in those participants who are transiently or persistently HIV-1-infected compared to placebo recipients who become HIV-1-infected. If the vaccine does not prevent HIV-1 infection, it will be important to characterize the course of the disease as measured by longitudinal viral load measurements, CD4+ counts, and clinical symptoms. Understanding the breadth, magnitude, and specificity of the immune response in partially or fully immunized vaccinees after infection and the impact on clinical symptoms and disease progression can potentially result in valuable information for the subsequent design of vaccine efficacy trials and, ultimately, in consideration of potential effectiveness of HIV-1 vaccines.

Study visits occur at Days 0, 7, 14, 28, then at 2 months, 3 months, 6 months, and every 6 months thereafter. At these visits, patients are given a physical exam, blood is drawn, and a donation of genital fluids is requested at certain visits. Patients are asked to donate samples of either semen (men) or cervical secretions (women); viral load is measured and compared to the amount and types of virus in the blood. He/she may refuse to donate these genital fluids and still be eligible to remain in the study. Primary medical care or medications for HIV infection are not provided by this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria

• Participated in HVTN, AVEG, HIVNET Phase I or Phase II vaccine trials or HIV vaccine preparedness trial HVTN 903 and became HIV infected after study enrollment.

• Are able and willing to provide information so that they may be located.

Exclusion Criteria

• Have a medical or mental problem that, in the opinion of the investigator, would interfere with the study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Intervention

Other:
• Observation
Observation of participants who received HIV preventive vaccine and became infected.

Locations

Country	Name	City	State
Brazil	Hospital Escola Sao Francisco de Assis (HESFA)	Cidade Nova
Peru	Asociacion Civil Selva Amazonica	Iquitos	Loreto
Peru	Impacta - Asociacion Civil Impacta Salud y Educaci	Lima 18
South Africa	Perinatal HIV Research Unit, Chris Hani Baragwanat	Bertsham
South Africa	KOSH District HVTU	Klerksdorp	North West Province
South Africa	University of Cape Town. Institute of Infectious Diseases	Mowbray
United States	Jhu-Cir/Dc	Baltimore	Maryland
United States	Johns Hopkins Univ	Baltimore	Maryland
United States	University of MD - Inst. of Human Virology (IHV)	Baltimore	Maryland
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Fenway Community Health	Boston	Massachusetts
United States	Harvard University / Brigham and Women's Hospital	Boston	Massachusetts
United States	Vanderbilt Univ Hosp	Nashville	Tennessee
United States	Columbia Univ	New York	New York
United States	New York Blood Ctr / Union Square	New York	New York
United States	Miriam Hosp	Providence	Rhode Island
United States	Univ of Rochester Med Ctr	Rochester	New York
United States	Saint Louis University School of Medicine	Saint Louis	Missouri
United States	Mt Zion Hospital	San Francisco	California
United States	San Francisco Dept of Hlth / AIDS Office	San Francisco	California
United States	Fred Hutchinson Cancer Research Ctr	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
HIV Vaccine Trials Network	National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Brazil,  Peru,  South Africa, 

References & Publications (1)

Seage GR 3rd, Holte SE, Metzger D, Koblin BA, Gross M, Celum C, Marmor M, Woody G, Mayer KH, Stevens C, Judson FN, McKirnan D, Sheon A, Self S, Buchbinder SP. Are US populations appropriate for trials of human immunodeficiency virus vaccine? The HIVNET Vaccine Preparedness Study. Am J Epidemiol. 2001 Apr 1;153(7):619-27. — View Citation

External Links

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