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

Completed

• Conditions: HIV Infections
• Interventions: Drug: Antiretroviral therapy

• Registration Number: NCT00219934
• Lead Sponsor: Rockefeller University

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)

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.

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-15
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 399

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Antiretroviral therapy	acute or early in the course of HIV-1 infection, independent of decisions regarding therapy with HAART.
Group B	Antiretroviral therapy	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 Outcome Measures

Name	Time	Method
Development of AIDS or AIDS-defining conditions as per the CDC	end of study
Death due to therapy	end of study
Morbidity due to therapy	end of study
Death due to AIDS or AIDS-defining conditions	end of study

Secondary Outcome Measures

Name	Time	Method
HIV-1 RNA levels	duration of the study
T-cell subsets	duration of study

Trial Locations

Locations (1)

Rockefeller University Hospital; 🇺🇸 New York, New York, United States