A Study of HIV in Newly Infected Individuals

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000930
First received: November 2, 1999
Last updated: October 29, 2012
Last verified: October 2012
  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

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

Resource links provided by NLM:


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

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
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: 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 Blood Ctr
Bronx, New York, United States, 10456
Bronx-Lebanon Hosp Ctr
Bronx, New York, United States, 10453
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
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

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000930     History of Changes
Other Study ID Numbers: HIVNET 019
Study First Received: November 2, 1999
Last Updated: October 29, 2012
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Infection
Communicable Diseases
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 September 29, 2014