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
  Purpose

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)


Condition Intervention
HIV Infections
Drug: Antiretroviral therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Treated and Untreated Acute and Early HIV-1 Infection

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

PLASMA AND PERIPHERAL BLOOD MONONUCLEAR CELLS


Enrollment: 399
Study Start Date: February 2002
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
acute or early in the course of HIV-1 infection, independent of decisions regarding therapy with HAART.
Drug: Antiretroviral therapy
HAART 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
HAART therapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219934

Locations
United States, New York
Rockefeller University Hospital
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Aaron Diamond AIDS Research Center
Investigators
Principal Investigator: Martin Markowitz, MD Rockefeller University
  More Information

Additional Information:
No publications provided

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00219934     History of Changes
Other Study ID Numbers: MMA 0465
Study First Received: September 20, 2005
Last Updated: February 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
New HIV Infection
Acute HIV Infection
Primary HIV Infection
Acute Seroconversion Syndrome

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 14, 2014