Clinical trial NCT00029913: A Study of Patients Who Develop HIV Infection After Enrolling in HIV Vaccine Trials or HIV Vaccine Preparedness Trials
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Placebos
AIDS Vaccines
CD4 Lymphocyte Count
Disease Progression
Viral Load
HIV Preventive Vaccine
Lead sponsor: HIV Vaccine Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2002-01-25
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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