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A Study of HIV in Newly Infected Individuals

This study is ongoing, but not recruiting participants.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000930
  Purpose

The purpose of this study is to see how HIV reacts in the immune systems of patients who have recently been infected with HIV. This study also examines HIV's resistance to anti-HIV drugs in newly infected patients.

Certain populations are good candidates for participation in HIV vaccine trials. These groups include men who have sex with men, IV drug users, and women at risk of getting HIV through heterosexual contact. Learning how HIV behaves in these populations once they become infected can help with the planning of future HIV vaccine studies.


Condition
HIV Infections

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Prospective
Official Title:   Infected Participants Protocol: Evaluation of Natural History of HIV Infection in Newly HIV-Infected Persons in HIVNET Target Populations

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

Primary Outcome Measures:
  • Detection of changes in HIV phenotype and genotype [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Clinical progression rates [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Antiviral resistance [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Specimens appropriate for clinical and laboratory assessments and necessary for evaluation of study outcome measures


Groups/Cohorts
A
HIV-infected individuals enrolled in HIVNET D01
B
Individuals with newly acquired HIV infection

Detailed Description:

This study provides an opportunity to prospectively monitor markers of HIV infection and disease progression in cohorts suitable for HIV vaccine trials. The detection of changes in HIV phenotype and genotype, clinical progression rates, and antiretroviral resistance within study populations over time are important for planning future HIV vaccine trials.

This study consists of two parts. Part A includes HIV-infected patients who enrolled in HIVNET D01.1 (infected-participants cohort of HIVNET D01) and whose HIV disease has been closely monitored and characterized. This study continues to monitor these patients with follow-up evaluations every 3 months for the first 18 months and then every 6 months thereafter. Part B includes newly HIV-infected patients. These patients are monitored with clinical and laboratory evaluations at 0, 1, 3, 6, 9, 12, and 18 months, and then every 6 months through Year 5.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Criteria

Inclusion Criteria

Patients must have:

  • HIV infection, as documented by enrollment in HIVNET D01.1 (Part A patients) or by standard HIV serological tests or demonstrated HIV infection on virologic assay (Part B patients).

Part A only:

  • Previous enrollment in infected-participants cohort of HIVNET D01.

Part B only:

  • Initial HIV-seronegativity on an HIVNET protocol (other than an HIV vaccine protocol) and testing positive for HIV at a subsequent clinic visit.
  • Confirmation of HIV infection and documentation of HIV negative antibody test within 8 months of first positive test.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

  • An obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation in the study.

Prior Medication:

Excluded:

  • Participation in a HIVNET HIV vaccine trial.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000930

Locations
United States, California
Los Angeles County / Health Research Assoc / Drew Med Ctr    
      Los Angeles, California, United States, 90033
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
United States, Maryland
Johns Hopkins Univ    
      Baltimore, Maryland, United States, 21205
United States, Massachusetts
Fenway Community Health Ctr / HIVNET    
      Boston, Massachusetts, United States, 02115
United States, New York
New York Univ Med Ctr    
      New York, New York, United States, 10016
Bronx-Lebanon Hosp Ctr    
      Bronx, New York, United States, 10453
New York Blood Ctr    
      Bronx, New York, United States, 10456
United States, Pennsylvania
Univ of Pennsylvania / HIVNET    
      Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
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:     Celum C    
Study Chair:     Buchbinder S    
Study Chair:     Sheppard H    
  More Information


Responsible Party:   DAIDS ( Rona Siskind )
Study ID Numbers:   HIVNET 019
First Received:   November 2, 1999
Last Updated:   September 23, 2008
ClinicalTrials.gov Identifier:   NCT00000930
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Sexual Partners  
Drug Resistance, Microbial  
Cohort Studies  
Risk Factors  
Substance Abuse, Intravenous  
Disease Progression
Homosexuality, Male
Genotype
Phenotype

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Disease Progression
Retroviridae Infections
Immunologic Deficiency Syndromes
Substance Abuse, Intravenous

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on October 31, 2008




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