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

NCT02614950 | Completed DMC

• 1 other identifier: SEARCH 022
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute HIV Infection; Antiretroviral Treatment Interruption

Outcome Measures

Primary Outcomes (1)

• HIV-1 RNA< 50 cps/ml

  24 weeks after ATI

Study Arms (1)

Treatment interuption

EXPERIMENTAL

Other: Treatment interruption

Interventions

Treatment interruption OTHER

Treatment interuption

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• SEARCH Research Foundation: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institute of Mental Health (NIMH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• US Military HIV Research Program: collaborator

Study Sites (1)

SEARCH Thailand

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Interventions

Treatment Interruption

Intervention Hierarchy (Ancestors)

Treatment Adherence and Compliance; Attitude to Health; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Nittaya - Phanuphak, MD, PhD

  SEARCH Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nittaya Phanuphak, MD, PhD

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 25, 2015
• Study Start: February 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

TH (1)