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

Official Title: “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.

Intervention(s) in this Clinical Trial

• Drug: Antiretroviral therapy
  • HAART therapy

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Development of AIDS or AIDS-defining conditions as per the CDC
  • Time Frame: end of study
    Safety Issue?: No
• Death due to AIDS or AIDS-defining conditions
  • Time Frame: end of study
    Safety Issue?: No
• Morbidity due to therapy
  • Time Frame: end of study
    Safety Issue?: No
• Death due to therapy
  • Time Frame: end of study
    Safety Issue?: No

Secondary Measures

• HIV-1 RNA levels
  • Time Frame: duration of the study
    Safety Issue?: No
• T-cell subsets
  • Time Frame: duration of study
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Rockefeller University Other

Overall Clinical Trial Officials and Contacts

Martin Markowitz, MD Principal Investigator Rockefeller University  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00219934

Study ID Number: MMA 0465

ClinicalTrials.gov Identifier: NCT00219934

Health Authority: United States: Institutional Review Board

The Aaron Diamond AIDS Research Center