Structured Treatment Interruption (STI) in Acute/Primary HIV
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gradual anti-HIV treatment interruption
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Only patients with Acute or Primary HIV infection will be studied
Eligibility Criteria
Inclusion Criteria:
- Patients with Acute HIV infection, where the time from infection to seroconversion is from 6 to 12 weeks
- Patients with Primary HIV infection, where the time from appearance of HIV antibodies seroconversion until the setpoint is less than 6 months
- Post menopausal females or potentially fertile women who agree either to refrain from sexual relations or to use contraceptive devices
- Patients who are willing to participate and who understand the trial, can read and sign the agreement form prior to entering the study
Exclusion Criteria:
- Patients suffering from serious disease, including hepatic or renal insufficiency and following organ transplantation
- Pregnant females or potentially fertile women who are unwilling to refrain from sexual relations or to use contraceptive devices
- Patients requiring chemotherapy or radiotherapy up till six months before entering the trial
Sites / Locations
Outcomes
Primary Outcome Measures
CD4 Cells normal value and Viral load undetectable (<50 per ml)
Secondary Outcome Measures
Full Information
NCT ID
NCT01293513
First Posted
February 8, 2011
Last Updated
February 9, 2011
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01293513
Brief Title
Structured Treatment Interruption (STI) in Acute/Primary HIV
Official Title
Structured Treatment Interruption (STI) in Acute/Primary HIV
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Although the introduction of Highly Active Anti-Retroviral Therapy - HAART - has dramatically altered the course of HIV/AIDS, true cure is still unattainable and patients are required to take these medications for the rest of their lives. As is well known, the prolonged use of such agents is associated with serious, sometimes life-threatening side effects, metabolic disturbances such as diabetes and an increased incidence of myocardial infarction.
In 1999, a patient with acute HIV infection was treated soon after diagnosis ("Berlin patient"). However because of intercurrent conditions, treatment was interrupted on two occasions. After the third introduction of therapy, treatment was terminated (arbitrarily) and the patient was found to have undetectable virus throughout a follow up of approximately 18 months. The possible explanation of this phenomenon was autovaccination. Other workers have tried Structured Treatment Interruption (STI) in Acute/Primary HIV Infection with controversial results, possibly because there were too few cycles of treatment interruption.
In a patient treated in our center for Acute HIV infection, after initial HAART therapy, he underwent gradually increasing interruptions of treatment from 1 to 7 weeks. After complete cessation of treatment, the patient was followed for 3 years, where CD4 levels were normal, CD4/CD8 ratio remained above 1 and the viral load was undetectable.
Our plan is to study patients with Acute/Primary HIV Infection, who have been treated with HAART for at least one year. Once they have been shown to have undetectable virus (less than 40 copies HIV RNA per milliliter) and CD4 above 500 per microliter with a CD4/CD8 above 1, they can be enrolled in the STI study.
The study will comprise 6 groups of 4 cycles of treatment/interruption with an increasing duration treatment interruptions alternating with treatment intervals over a 33 month period. Altogether there will be 24 treatment interruptions, lasting from 1 week to 6 weeks. During this time the patients will be regularly monitored for clinical events and laboratory parameters.
The purpose of the study is to determine whether patients with acute/primary HIV infection undergoing graded STI can achieve a normal immune status and undetectable viral load on a long-term basis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Only patients with Acute or Primary HIV infection will be studied
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Gradual anti-HIV treatment interruption
Other Intervention Name(s)
STI (Structured treatment interruption)
Intervention Description
Gradual interruption of anti-HIV treatment: the interruption initially for a week, up to six weeks' interruption, and continuing anti-HIV treatment for two weeks between successive interruptions
Primary Outcome Measure Information:
Title
CD4 Cells normal value and Viral load undetectable (<50 per ml)
Time Frame
33 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Acute HIV infection, where the time from infection to seroconversion is from 6 to 12 weeks
Patients with Primary HIV infection, where the time from appearance of HIV antibodies seroconversion until the setpoint is less than 6 months
Post menopausal females or potentially fertile women who agree either to refrain from sexual relations or to use contraceptive devices
Patients who are willing to participate and who understand the trial, can read and sign the agreement form prior to entering the study
Exclusion Criteria:
Patients suffering from serious disease, including hepatic or renal insufficiency and following organ transplantation
Pregnant females or potentially fertile women who are unwilling to refrain from sexual relations or to use contraceptive devices
Patients requiring chemotherapy or radiotherapy up till six months before entering the trial
12. IPD Sharing Statement
Learn more about this trial
Structured Treatment Interruption (STI) in Acute/Primary HIV
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