NCT00000911

Brief Summary

The purpose of this study is to monitor patients who recently have been infected with HIV in order to learn how their immune systems respond to HIV infection and to study how the virus acts in their bodies. Primary HIV infection occurs within 20 days to 8 weeks following exposure to HIV. The symptoms of primary HIV infection are usually fever, tiredness, headache, or muscle aches. However, symptoms vary greatly from person to person, and some people might not experience any symptoms at all. Because these symptoms also resemble the cold or the flu, it is difficult to identify patients with primary HIV infection. Information gathered from this study will help doctors decide what kind of treatment is best to give patients who recently have been infected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1999

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

7.7 years

First QC Date

November 2, 1999

Last Update Submit

October 21, 2015

Conditions

HIV Infections

Keywords

SemenHIV-1Immunity, CellularLymph NodesViremiaAntibodies, ViralVaginaViral LoadAcute Infection

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have recently been infected with HIV

You may qualify if:

  • Patients may be eligible for 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, lymph node tissue, CSF, and semen or vaginal secretion specimens

MeSH Terms

Conditions

HIV InfectionsViremia

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Susan Little

    PRINCIPAL INVESTIGATOR

  • Diane Havlir

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Start

October 1, 1999

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

October 22, 2015

Record last verified: 2015-10

Locations

US(1)