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Observational Study of Treated and Untreated Acute and Early HIV-1 Infection

This study has been completed.
Sponsor:
Collaborator:
Aaron Diamond AIDS Research Center
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00219934
First received: September 20, 2005
Last updated: February 15, 2012
Last verified: February 2012

September 20, 2005
February 15, 2012
February 2002
November 2010   (final data collection date for primary outcome measure)
  • Development of AIDS or AIDS-defining conditions as per the CDC [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Death due to AIDS or AIDS-defining conditions [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Morbidity due to therapy [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Death due to therapy [ Time Frame: end of study ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00219934 on ClinicalTrials.gov Archive Site
  • HIV-1 RNA levels [ Time Frame: duration of the study ] [ Designated as safety issue: No ]
  • T-cell subsets [ Time Frame: duration of study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Observational Study of Treated and Untreated Acute and Early HIV-1 Infection
Observational Study of Treated and Untreated Acute and Early HIV-1 Infection

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)

At the initial visit: subjects will undergo a complete history and physical examination. They will have blood drawn for HIV-1 antibody testing, resistance testing, and lymphocyte subsets. In addition, blood will be drawn for hematology, chemistries, and syphilis, and Hepatitis B and C serologies.

Individuals in Group B will not have HIV-1 antibody testing, resistance testing, or Hepatitis B and C serologies performed, as these would have been performed as part of their current protocol. Individuals electing to initiate antiretroviral therapy will obtain standard HAART as prescribed by their physicians.

Group A subjects will be seen at Weeks 4, and 12 ,then every 12 weeks until week 48, then every 24 weeks until week 96. If treated during acute and early infection, then they will be seen every 48 weeks thereafter for 5 years. If untreated during acute and early infection, then they will be discontinued from the study.

Group B participants who have been followed for less than 96 weeks will be seen every 12 weeks until week 48, then every 24 weeks until week 96.

Participants currently enrolled beyond week 96 who were treated during acute and early infection, and whose treatment was uninterrupted, will be seen every 48 weeks. If participants were not treated during acute and early infection, or treatment was interrupted, then they will be discontinued from the study.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

PLASMA AND PERIPHERAL BLOOD MONONUCLEAR CELLS

Non-Probability Sample

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

HIV Infections
Drug: Antiretroviral therapy
HAART therapy
  • Group A
    acute or early in the course of HIV-1 infection, independent of decisions regarding therapy with HAART.
    Intervention: 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
    Intervention: Drug: Antiretroviral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
399
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

    1. a negative test for HIV-1 antibodies
    2. an indeterminate test for HIV-1 antibodies
    3. 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)
    4. a positive test for HIV-1 antibodies and a documented negative test within 6 months of presentation
    5. a positive test for HIV-1 antibodies with a simultaneous negative low sensitivity ("detuned") assay (S/C <15)
    6. 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

Exclusion Criteria:

  • Individuals less than 16 years of age
  • Individuals who are unable or unwilling to provide written informed consent
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00219934
MMA 0465
Yes
Rockefeller University
Rockefeller University
Aaron Diamond AIDS Research Center
Principal Investigator: Martin Markowitz, MD Rockefeller University
Rockefeller University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP