NCT00219934

Brief Summary

Group A: Long-term follow-up is needed for subjects identified as acute or early in the course of HIV-1 infection, independent of decisions regarding therapy with highly active anti-retroviral therapy (HAART). Group B: This protocol will also be offered to subjects who were diagnosed with acute HIV-1 infection in the past and have been participating in an ADARC/Rockefeller University Hospital treatment protocol for acute HIV-1 infection, and currently have a viral load consistently less than 50 copies/ml on current treatment (Group B)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
399

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2002

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

February 1, 2002

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

8.8 years

First QC Date

September 20, 2005

Last Update Submit

February 15, 2012

Conditions

HIV Infections

Keywords

New HIV InfectionAcute HIV InfectionPrimary HIV InfectionAcute Seroconversion Syndrome

Outcome Measures

Primary Outcomes (4)

  • Development of AIDS or AIDS-defining conditions as per the CDC

    end of study

  • Death due to AIDS or AIDS-defining conditions

    end of study

  • Morbidity due to therapy

    end of study

  • Death due to therapy

    end of study

Secondary Outcomes (2)

  • HIV-1 RNA levels

    duration of the study

  • T-cell subsets

    duration of study

Study Arms (2)

Group A

acute or early in the course of HIV-1 infection, independent of decisions regarding therapy with HAART.

Drug: Antiretroviral therapy

Group B

subjects who were diagnosed with acute HIV-1 infection in the past and have been participating in an ADARC/Rockefeller University Hospital treatment protocol for acute HIV-1 infection, and currently have a viral load consistently less than 50 copies/ml on current treatment

Drug: Antiretroviral therapy

Interventions

Antiretroviral therapyDRUG

HAART therapy

Group AGroup B

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited from the community or from existing ADARC clinical trials. Participants will give written informed consent.

You may qualify if:

  • Group A: HIV-1 infected individuals at least 16 years of age with HIV-1 RNA detectable in the blood (\>2000 copies/ml) and one of the following:
  • a negative test for HIV-1 antibodies
  • an indeterminate test for HIV-1 antibodies
  • a positive test for HIV-1 antibodies with an immature Western Blot (less than 5 bands) which subsequently matures (addition of 2 or more bands)
  • a positive test for HIV-1 antibodies and a documented negative test within 6 months of presentation
  • a positive test for HIV-1 antibodies with a simultaneous negative low sensitivity ("detuned") assay (S/C \<15)
  • Individuals must be able and willing to provide written informed consent
  • Group B: Approximately 90 individuals diagnosed with acute HIV-1 infection in the past who have been participating in an ADARC/Rockefeller University Hospital protocol involving treatment of acute HIV-1 infection and are currently on that regimen with HIV-1 RNA consistently less than 50 copies/ml and are interested in changing to a protease inhibitor-sparing regimen or may continue to be treated with medications provided or taken as part of a completed ADARC/RUH study of the treatment of acute and early HIV infection

You may not qualify if:

  • Individuals less than 16 years of age
  • Individuals who are unable or unwilling to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rockefeller University Hospital

New York, New York, 10065, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

PLASMA AND PERIPHERAL BLOOD MONONUCLEAR CELLS

MeSH Terms

Conditions

HIV Infections

Interventions

Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy, CombinationDrug TherapyTherapeutics

Study Officials

  • Martin Markowitz, MD

    Rockefeller University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

February 1, 2002

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

February 17, 2012

Record last verified: 2012-02

Locations

US(1)