A Study to Monitor the Health of Participants in HIVNET 014 Who Become Infected With HIV-1

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001121
First received: November 2, 1999
Last updated: September 11, 2008
Last verified: June 2003
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Official Title: Evaluation of Virologic, Immunologic, and Clinical Parameters of Participants in HIVNET 014 Who Become Infected With HIV-1

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Study Start Date: August 1999
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001121

Locations
United States, California
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, United States, 94102
United States, Colorado
Denver Dept of Public Health / HIVNET
Denver, Colorado, United States, 80204
United States, Illinois
Univ of Illinois Chicago / Howard Brown Hlth Ctr
Chicago, Illinois, United States, 60612
Howard Brown Health Ctr / HIVNET
Chicago, Illinois, United States, 60657
United States, Massachusetts
Fenway Community Health Ctr / HIVNET
Boston, Massachusetts, United States, 02115
United States, New York
New York Blood Ctr
Bronx, New York, United States, 10456
New York Univ Med Ctr
New York, New York, United States, 10016
United States, Pennsylvania
Univ of Pennsylvania / HIVNET
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, United States, 02860
Miriam Hosp
Providence, Rhode Island, United States, 02906
United States, Washington
Univ of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Investigators
Study Chair: Connie Celum
Study Chair: Susan Buchbinder
Study Chair: Haynes Sheppard
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00001121     History of Changes
Other Study ID Numbers: HIVNET 014A
Study First Received: November 2, 1999
Last Updated: September 11, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Placebos
AIDS Vaccines
Follow-Up Studies
HIV Therapeutic Vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 02, 2014