Clinical trial NCT00001121: A Study to Monitor the Health of Participants in HIVNET 014 Who Become Infected With HIV-1
Official title: Evaluation of Virologic, Immunologic, and Clinical Parameters of Participants in HIVNET 014 Who Become Infected With HIV-1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Placebos
AIDS Vaccines
Follow-Up Studies
HIV Therapeutic Vaccine
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to evaluate the long-term consequences of HIV-1 infections that occurred in association with known, but discouraged, high-risk behaviors in persons who have received HIV candidate vaccines or placebo in HIVNET 014. Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS.

Patients who receive HIV vaccines are sometimes protected from HIV infection. More often, these patients become HIV-positive but experience a boost in their immune system that helps their bodies fight HIV. Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS.

Detailed description: There are many possible outcomes of HIV-1 infection among persons who receive experimental HIV-1 vaccines. In the best-case scenario, these vaccines may prevent infection (sterilizing immunity). However, current viral vaccines are thought to limit, but not prevent, virus replication after infection. In the latter case, it is important to document the effect of the immune response on the disease course as reflected by viral load, the evolution of the viral quasi species, and clinical symptoms over time. Understanding the evolution of the immune response in vaccinees after subsequent exposure and HIV infection will potentially result in valuable information for the subsequent design of preventive and therapeutic vaccines. This will be studied here using HIVNET 014 participants at higher risk for HIV-1 infection.

Participants discontinue HIVNET 014 vaccinations upon confirmation of HIV-1 infection and are enrolled in this study. Participants undergo clinical and laboratory examinations every 3 months for the first year of follow-up and every 6 months for at least 4 years thereafter. Additionally, HIV-infected partners of HIVNET 014A participants undergo clinical and laboratory examination at enrollment, and may be asked to donate additional specimens at a later time. Study endpoints include various virologic, immunologic, and clinical parameters, such as viral load, cellular immune response, and virus phenotype and genotype.

Eligibility criteria: Inclusion Criteria

Patients may be eligible for this study if they:

* Become infected with HIV while participating in HIVNET 014, or if they are an HIV-positive partner (sexual or needle-sharing) of a HIVNET 014A participant.
* Are able and willing to provide written informed consent.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have a serious psychiatric or psychological disorder that would prevent them from completing the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Dept of Hlth / AIDS Office
state: California
city: Denver
country: United States
facility: Denver Dept of Public Health / HIVNET
state: Colorado
city: Chicago
country: United States
facility: Univ of Illinois Chicago / Howard Brown Hlth Ctr
state: Illinois
city: Chicago
country: United States
facility: Howard Brown Health Ctr / HIVNET
state: Illinois
city: Boston
country: United States
facility: Fenway Community Health Ctr / HIVNET
state: Massachusetts
city: Bronx
country: United States
facility: New York Blood Ctr
state: New York
city: New York
country: United States
facility: New York Univ Med Ctr
state: New York
city: Philadelphia
country: United States
facility: Univ of Pennsylvania / HIVNET
state: Pennsylvania
city: Pawtucket
country: United States
facility: Mem Hosp of Rhode Island
state: Rhode Island
city: Providence
country: United States
facility: Miriam Hosp
state: Rhode Island
city: Seattle
country: United States
facility: Univ of Washington
state: Washington
Study officials:
name: Connie Celum
role: STUDY_CHAIR
name: Susan Buchbinder
role: STUDY_CHAIR
name: Haynes Sheppard
role: STUDY_CHAIR
References: