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

NCT ID: NCT00029913

Last Updated: 2010-09-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2009-07-31

Brief 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.

Detailed 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.

Conditions

HIV Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Observation of participants includes a physical exam and collection of fluids. Study visits occur at Days 0, 7, 14, 28 and at Months 2, 3, 6 and every 6 months thereafter.

Observation

Intervention Type: OTHER

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

Interventions

Observation

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

HIV Vaccine Trials Network

NETWORK

Sponsor Role: lead

Responsible Party

HVTN

Principal Investigators

Connie Celum, MD

Role: STUDY_CHAIR

University of Washington

Scott Hammer, MD

Role: STUDY_CHAIR

Columbia University

Locations

Univ of Alabama at Birmingham

Birmingham, Alabama, United States

Mt Zion Hospital

San Francisco, California, United States

San Francisco Dept of Hlth / AIDS Office

San Francisco, California, United States

University of MD - Inst. of Human Virology (IHV)

Baltimore, Maryland, United States

Jhu-Cir/Dc

Baltimore, Maryland, United States

Johns Hopkins Univ

Baltimore, Maryland, United States

Fenway Community Health

Boston, Massachusetts, United States

Harvard University / Brigham and Women's Hospital

Boston, Massachusetts, United States

Saint Louis University School of Medicine

St Louis, Missouri, United States

New York Blood Ctr / Union Square

New York, New York, United States

Columbia Univ

New York, New York, United States

Univ of Rochester Med Ctr

Rochester, New York, United States

Miriam Hosp

Providence, Rhode Island, United States

Vanderbilt Univ Hosp

Nashville, Tennessee, United States

Fred Hutchinson Cancer Research Ctr

Seattle, Washington, United States

Hospital Escola Sao Francisco de Assis (HESFA)

Cidade Nova, , Brazil

Asociacion Civil Selva Amazonica

Iquitos, Loreto, Peru

Impacta - Asociacion Civil Impacta Salud y Educaci

Lima, , Peru

KOSH District HVTU

Klerksdorp, North West, South Africa

Perinatal HIV Research Unit, Chris Hani Baragwanat

Bertsham, , South Africa

University of Cape Town. Institute of Infectious Diseases

Mowbray, , South Africa

Countries

United States; Brazil; Peru; South Africa

References

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. doi: 10.1093/aje/153.7.619.

Reference Type: BACKGROUND

PMID: 11282787 (View on PubMed)

Other Identifiers

5U01AI068614

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HVTN 403

Identifier Type: -

Identifier Source: org_study_id