Philadelphia, Pennsylvania 19104

  • HIV Infections


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.

Study summary:

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.


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.

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

A Study of HIV in Newly Infected Individuals

Official Title:

Infected Participants Protocol: Evaluation of Natural History of HIV Infection in Newly HIV-Infected Persons in HIVNET Target Populations

Overall Status:


Study Phase:




Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Study Type:


Study Design:

Observational Model: Case-Only, Time Perspective:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Overall Contact Information

Official Name:Celum C
Study Chair

Study Dates

Completion Date:May 2008
Completion Type:Actual
Primary Completion Date:May 2008
Primary Completion Type:Actual
Verification Date:October 2012
Last Changed Date:November 4, 2016
First Received Date:November 2, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:Antiviral resistance
Time Frame:Throughout study
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Clinical progression rates
Time Frame:Throughout study
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Detection of changes in HIV phenotype and genotype
Time Frame:Throughout study
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:B
Description:Individuals with newly acquired HIV infection
Study Arm Type:Other
Arm Name:A
Description:HIV-infected individuals enrolled in HIVNET D01

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Samples and Retentions

Sample Retention:Samples With DNA
Description: Specimens appropriate for clinical and laboratory assessments and necessary for evaluation of study outcome measures
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source:

Date Processed: March 30, 2020

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