Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intermittent ART in Primary HIV Infection (PHI-IL2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02300623
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : November 25, 2014
Sponsor:
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona

Brief Summary:
Interventions during primary HIV infection (PHI) can modify the immune control and the clinical evolution during the chronic phase. Although several studies suggest the benefit of antiretroviral treatment (ART) during PHI, indication of ART is still not universally recommended. The investigators randomized patients with PHI, with a favourable immunological profile and well controlled on ART, to undergone structured treatment interruptions alone or with low doses of IL-2, stopping ART thereafter. The endpoints were immune control of HIV replication and time to resume ART. Immunological profile, specific CD4 and CD8 responses and clinical data were analysed for both groups up to 48 weeks, and during a long follow-up, up to nine years since final ART stop.

Condition or disease Intervention/treatment Phase
HIV Drug: Antiretroviral therapy plus Interleukin-2 Drug: Antiretroviral therapy alone Phase 4

Detailed Description:
The study design included two phases. The first phase consisted in four STI of 8 weeks each (off-ART), separated by 16 weeks of treatment -or the time necessary to reach again to PVL <20 copies/mL- (on-ART). At the end of the 4th off-ART cycle (week 0) an interim evaluation was performed and the second phase initiated. During the second phase, the first 6 patients received ART until they reach PVL<20 copies/mL, discontinuing thereafter (final stop). The last 6 patients received ART and low doses of IL-2. ARV therapy was stopped after reaching PVL<20 copies/mL (final stop) and IL-2 after 6 months of treatment. IL-2 was prescribed at a dose of 750.000 UI/m2 daily and was self-administrated in all patients previous trained by a specialized nurse. ART was resumed in patient dropping CD4 cell count less than 350 cell/mm3 in two consecutive determinations or in patients who developed opportunistic infections. A long term follow up analysis was performed at 3, 6 and 9 years since the final stop. It included time to resume ART, clinical events, survival rate, CD4-CD8-CD4/CD8 ratio.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Term Follow-up of Patients Experiencing Structured Treatment Interruption (STI) With or Without Low Doses of Interleukin-2 During Primary HIV Infection (PHI)
Study Start Date : March 2000
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Control
Antiretroviral therapy alone
Drug: Antiretroviral therapy alone
Standard antiretroviral therapy
Other Names:
  • stavudine
  • Lamivudine
  • Indinavir

Experimental: Treatment
Antiretroviral therapy plus Interleukin-2'
Drug: Antiretroviral therapy plus Interleukin-2
Daily s.c. IL-2: 750,000 UI/m2/day for 6 months
Other Names:
  • IL-2
  • Stavudine
  • Lamivudine
  • Indinavir




Primary Outcome Measures :
  1. Control of viral replication without ART. [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Time to resume ART. [ Time Frame: 9 years after final stop ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PHI defined by detectable plasma viral load (PVL) or p24 antigen detection coupled with a negative or indeterminate LIA assay (according CDC criteria); negative HIV-1 EIA in the preceding 90 days or by a positive EIA and LIA assay with acute retroviral syndrome in the preceding 90 days of starting ART plus documented negative HIV-1 EIA within the previous year.
  • ART started within 90 days from the HIV exposure and continuing in the same treatment at least 12 months before the inclusion, and they must have shown good virological and immunological responses, defined as undetectable PVL (<20 copies/mL in the last two controls) and CD4 more than 500 cells/mm3 with a CD4/CD8 ratio >1 in the last 8 months previous to enrolment

Exclusion Criteria:

  • Infection of more than 90 days.
  • Age under 18 years old.
  • AIDS defining condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300623


Locations
Layout table for location information
Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Juan A. Arnaiz
Investigators
Layout table for investigator information
Principal Investigator: Josep Maria Miró, MDPhD Hospital Clinic of Barcelona

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Juan A. Arnaiz, MD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02300623     History of Changes
Other Study ID Numbers: PHI-IL2
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Retroviral Agents
Lamivudine
Stavudine
Indinavir
Interleukin-2
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antimetabolites
HIV Protease Inhibitors
Protease Inhibitors