Viral Suppression After Analytic Treatment Interruption in Thai Patients Who Initiated Highly Active Antiretroviral Therapy During Acute HIV Infection
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|ClinicalTrials.gov Identifier: NCT02614950|
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : January 27, 2017
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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 or disease||Intervention/treatment||Phase|
|Acute HIV Infection Antiretroviral Treatment Interruption||Other: Treatment interruption||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Viral Suppression After Analytic Treatment Interruption in Thai Patients Who Initiated Highly Active Antiretroviral Therapy During Acute HIV Infection|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||December 2016|
|Experimental: Treatment interuption||
Other: Treatment interruption
- HIV-1 RNA< 50 cps/ml [ Time Frame: 24 weeks after ATI ]
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|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
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): NCT02614950
|Bangkok, Thailand, 10330|
|Principal Investigator:||Nittaya - Phanuphak, MD, PhD||South East Asia Research Collaboration with Hawaii|
|Responsible Party:||Nittaya Phanuphak, MD, PhD, South East Asia Research Collaboration with Hawaii|
|Other Study ID Numbers:||
|First Posted:||November 25, 2015 Key Record Dates|
|Last Update Posted:||January 27, 2017|
|Last Verified:||January 2017|
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases