Structured Treatment Interruption (STI) in Acute/Primary HIV

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2011 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01293513
First received: February 8, 2011
Last updated: February 9, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
HIV Infections
Other: Gradual anti-HIV treatment interruption

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Structured Treatment Interruption (STI) in Acute/Primary HIV

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • CD4 Cells normal value and Viral load undetectable (<50 per ml) [ Time Frame: 33 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: February 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Gradual anti-HIV treatment interruption
    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
    Other Name: STI (Structured treatment interruption)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Prof. Israel Yust, Kobler AIDS Center, Tel Sourasky Medical Center ISRAEL
ClinicalTrials.gov Identifier: NCT01293513     History of Changes
Other Study ID Numbers: TASMC-10-IY-0190-10-TLV-CTIL
Study First Received: February 8, 2011
Last Updated: February 9, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Only patients with Acute or Primary HIV infection will be studied

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Infection
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 22, 2014