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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219934
• Other study ID #: MMA 0465
• Status: Completed
• Phase: N/A
• First received: September 20, 2005
• Last updated: February 15, 2012
• Start date: February 2002
• Est. completion date: November 2010

Study information

• Verified date: February 2012
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infection

Intervention

Drug:
• Antiretroviral therapy
HAART therapy

Locations

Country	Name	City	State
United States	Rockefeller University Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Rockefeller University	Aaron Diamond AIDS Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of AIDS or AIDS-defining conditions as per the CDC		end of study	No
Primary	Death due to AIDS or AIDS-defining conditions		end of study	No
Primary	Morbidity due to therapy		end of study	No
Primary	Death due to therapy		end of study	No
Secondary	HIV-1 RNA levels		duration of the study	No
Secondary	T-cell subsets		duration of study	No

External Links

•   The Aaron Diamond AIDS Research Center