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

August 31, 2010 updated by: HIV Vaccine Trials Network

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Cidade Nova, Brazil, 20210-303
        • Hospital Escola Sao Francisco de Assis (HESFA)
  • Peru
      • Lima 18, Peru
        • Impacta - Asociacion Civil Impacta Salud y Educaci
    • Loreto
      • Iquitos, Loreto, Peru
        • Asociacion Civil Selva Amazonica
  • South Africa
      • Bertsham, South Africa, 2013
        • Perinatal HIV Research Unit, Chris Hani Baragwanat
      • Mowbray, South Africa, 7705
        • University of Cape Town. Institute of Infectious Diseases
    • North West Province
      • Klerksdorp, North West Province, South Africa, 2571 SF
        • KOSH District HVTU
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ of Alabama at Birmingham
    • California
      • San Francisco, California, United States, 94102
        • Mt Zion Hospital
      • San Francisco, California, United States, 94102
        • San Francisco Dept of Hlth / AIDS Office
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Univ
      • Baltimore, Maryland, United States, 21201
        • University of MD - Inst. of Human Virology (IHV)
      • Baltimore, Maryland, United States, 21205
        • Jhu-Cir/Dc
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Fenway Community Health
      • Boston, Massachusetts, United States, 02115
        • Harvard University / Brigham and Women's Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University School of Medicine
    • New York
      • New York, New York, United States, 10032
        • Columbia Univ
      • New York, New York, United States, 10003
        • New York Blood Ctr / Union Square
      • Rochester, New York, United States, 14642
        • Univ of Rochester Med Ctr
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hosp
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Univ Hosp
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants who were enrolled in HIV preventive vaccine clinical trials and became HIV infected as a result of the vaccine.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Observation
Observation of participants who received HIV preventive vaccine and became infected.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HIV Vaccine Trials Network

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Connie Celum, MD, University of Washington
  • Study Chair: Scott Hammer, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

January 24, 2002

First Submitted That Met QC Criteria

January 24, 2002

First Posted (Estimate)

January 25, 2002

Study Record Updates

Last Update Posted (Estimate)

September 2, 2010

Last Update Submitted That Met QC Criteria

August 31, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HVTN 403
  • 5U01AI068614 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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