NCT00001093

Brief Summary

The purpose of this study is to find out if it is effective to give aggressive anti-HIV therapy to patients who have been infected recently with HIV. Many doctors recommend that patients who have recently been infected with HIV begin anti-HIV treatment as soon as possible. However, early HIV infection is not yet completely understood, so it is not known if this is the best approach. This study will look at the effects of beginning anti-HIV treatment during early HIV infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 1999

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

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

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

First QC Date

November 2, 1999

Last Update Submit

October 26, 2012

Conditions

HIV Infections

Keywords

Immunity, CellularSexual PartnersTreatment OutcomeAnti-HIV AgentsViral LoadAcute Infection

Eligibility Criteria

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

You may qualify if:

  • Patients may be eligible for this study if they:
  • Are at least 13 years old.
  • Have acute or early HIV infection. The stage of HIV infection will depend on the results from certain lab tests.

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Are pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cedars Sinai Med Ctr

Los Angeles, California, 90048, United States

Location

UCSD

San Diego, California, 92103, United States

Location

San Francisco Gen Hosp / UCSF AIDS Program

San Francisco, California, 94110, 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

  • James Kahn

    PRINCIPAL INVESTIGATOR

  • Eric Daar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Start

October 1, 1999

Study Completion

June 1, 2007

Last Updated

October 29, 2012

Record last verified: 2012-10

Locations

US(3)