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Viral Suppression After Analytic Treatment Interruption in Thai Patients Who Initiated Highly Active Antiretroviral Therapy During Acute HIV Infection

This study has been completed.
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
US Military HIV Research Program
Information provided by (Responsible Party):
Nittaya Phanuphak, MD, PhD, South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier:
NCT02614950
First received: November 23, 2015
Last updated: January 25, 2017
Last verified: January 2017
  Purpose

This is a Phase 2, two-step, open-label study of the outcome of analytic treatment interruption (ATI) on patients who started antiretroviral therapy (ART) during Fiebig Stage I of acute HIV infection (AHI), defined as detectable HIV-RNA without detectable p24 antigen or HIV IgM. The primary endpoint will be rate of sustained viral suppression, defined as HIV-1 RNA < 50 cps/ml at 24 weeks after treatment interruption. During ATI subjects will be monitored closely for safety and will have ART re-initiated if they meet predefined clinical, virological, or immunological criteria. In step I, there will be 8 subjects who undergo ATI. An interim analysis for safety will be conducted after 12 weeks. If none of the subjects maintain viral suppression at 12 weeks then no further subjects will be enrolled into the study. If at least 1 out of 8 subjects maintains viral suppression at 12 weeks then an additional 7 subjects will be enrolled in step 2.

At ATI all antiretroviral drugs will be discontinued. Subjects will be monitored with clinical exam, immunological (CD4), and virological (HIV-RNA) testing at baseline and then on a fixed schedule for 24 weeks. ART will be re-initiated immediately if subjects meet any pre-defined clinical, immunological or virological safety endpoints during the monitoring period.


Condition Intervention
Acute HIV Infection
Antiretroviral Treatment Interruption
Other: Treatment interruption

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Viral Suppression After Analytic Treatment Interruption in Thai Patients Who Initiated Highly Active Antiretroviral Therapy During Acute HIV Infection

Resource links provided by NLM:


Further study details as provided by South East Asia Research Collaboration with Hawaii:

Primary Outcome Measures:
  • HIV-1 RNA< 50 cps/ml [ Time Frame: 24 weeks after ATI ]

Enrollment: 8
Study Start Date: February 2016
Study Completion Date: December 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment interuption Other: Treatment interruption

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject currently enrolled in SEARCH 010/RV254 Acute HIV Infection cohort.
  • Male and females aged > 18 years.
  • Fiebig Stage I at entry to SEARCH 010/RV254 cohort.
  • Taking ART > 24 months.
  • HIV-1 RNA < 50 cps/ml for the past 12 months
  • Integrated HIV in PBMCs below level of detection (1 copy/105 PBMCs) within the last 6 months
  • Most recent (within 3 months) peripheral blood CD4 count > 400 cells/mm3
  • No HIV-related or AIDS Defining illness within the last 6 months (Appendix 1)
  • Ability and willingness to provide written informed consent.
  • Female-specific Criteria:
  • Agrees not to become pregnant from the time of study enrollment until the last study visit. If a woman is sexually active and has no history of hysterectomy or tubal ligation or menopause, she must agree to use a prescription birth control method or a barrier birth control method.
  • Negative β-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for any women unless she is post-menopause for 24 consecutive months or has undergone a surgical procedure that precludes pregnancy

Exclusion Criteria:

  • Pregnancy or breast-feeding.
  • Untreated Syphilis
  • Hepatitis B surface antigen positive at any time in the past.
  • Hepatitis C antibody positive at any time in the past.
  • Serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent.
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements or to give informed consent.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02614950

Locations
Thailand
SEARCH Thailand
Bangkok, Thailand, 10330
Sponsors and Collaborators
South East Asia Research Collaboration with Hawaii
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
US Military HIV Research Program
Investigators
Principal Investigator: Nittaya - Phanuphak, MD, PhD South East Asia Research Collaboration with Hawaii
  More Information

Responsible Party: Nittaya Phanuphak, MD, PhD, South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier: NCT02614950     History of Changes
Other Study ID Numbers: SEARCH 022
Study First Received: November 23, 2015
Last Updated: January 25, 2017

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
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 March 30, 2017