NCT00001092

Brief Summary

The purpose of this study is to look at the amount of HIV in the blood, genital fluid, and saliva of the partners of patients with early HIV infection. This study will also look at the strength of the immune systems of patients with early HIV infection. Because HIV multiplies very quickly in the early stages of infection, patients with early HIV infection may be more likely to transmit HIV to their partners. The amount of HIV in blood, genital fluid, and saliva may determine the risk for transmission.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 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
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

9 years

First QC Date

November 2, 1999

Last Update Submit

October 21, 2015

Conditions

HIV Infections

Keywords

SemenHIV-1Sexual PartnersDrug Resistance, MicrobialCD8-Positive T-LymphocytesSalivaBloodCervix UteriVaginaAcute Infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV-infected adults with recent seroconversion

You may qualify if:

  • Patients may be eligible for this study if they:
  • Are at least 18 years old.
  • Have sex with or share injection drugs with a person who is thought to have early HIV infection, or if they have recently become HIV-positive.
  • Can provide written consent.
  • Are available for a follow-up period of at least 4 weeks.

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

Biospecimen

Retention: SAMPLES WITH DNA

Blood, genital fluids, and saliva collection

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

  • James Kahn

    PRINCIPAL INVESTIGATOR

  • Margaret Chesney

    PRINCIPAL INVESTIGATOR

  • Rick Hecht

    PRINCIPAL INVESTIGATOR

  • Susan Little

    PRINCIPAL INVESTIGATOR

  • Eric Daar

    PRINCIPAL INVESTIGATOR

  • Jay Levy

    PRINCIPAL INVESTIGATOR

  • Robert Grant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Start

October 1, 1999

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

October 22, 2015

Record last verified: 2015-10

Locations

US(3)