NCT00005020

Brief Summary

The purpose of this study is to monitor patients who have recently been infected with HIV in order to learn how their immune systems respond to HIV infection and to study how the virus multiplies in their bodies. Patients who have been infected with HIV recently are considered to have acute, or early, HIV infection. During this period, viral load (level of HIV in the body) rises sharply to a high level at first but then decreases significantly on its own. Doctors are not sure why this decrease in viral load happens and how the body is able to accomplish this. In this study, patients with acute HIV infection will be monitored so that doctors can study their immune systems to try to learn more about this rise and fall in viral load.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2000

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

March 25, 2010

Status Verified

December 1, 2004

First QC Date

April 6, 2000

Last Update Submit

March 24, 2010

Conditions

Keywords

CD4 Lymphocyte CountCD4-Positive T-LymphocytesPhenotypeViral LoadAcute Infection

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers may be eligible for Cohort I of this study if they:
  • Are at least 13 years old (consent of parent or guardian required if under 18).
  • Have no active infections or cancer.
  • Are HIV-negative.
  • Volunteers may be eligible for Cohort II of this study if they:
  • Are at least 13 years old (consent of parent or guardian required if under 18).
  • Have acute or early HIV infection. The stage of HIV infection will depend on the results of certain lab tests.
  • Agree not to take anti-HIV drugs the first 4 weeks of the study.

You may not qualify if:

  • Volunteers will not be eligible for this study if they:
  • Weigh less than 45 kg (99 pounds).
  • Have begun anti-HIV therapy.
  • Are pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joanne Santangelo

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Susan Little

    PRINCIPAL INVESTIGATOR
  • Diane Havlir

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

April 6, 2000

First Posted

August 31, 2001

Last Updated

March 25, 2010

Record last verified: 2004-12

Locations