HIV Infections Clinical Trial
Official title:
Safety and Therapeutic Efficacy of the Broadly Neutralizing HIV-1 Specific Monoclonal Antibody VRC01 During Analytic Treatment Interruption in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection
Verified date | October 2021 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study will evaluate the safety and therapeutic efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01), when administered during analytic treatment interruption (ATI), in adults who began antiretroviral therapy (ART) during early acute HIV infection.
Status | Completed |
Enrollment | 23 |
Est. completion date | August 4, 2017 |
Est. primary completion date | August 4, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 50 Years |
Eligibility | Inclusion Criteria: - Able and willing to provide written informed consent or, in the case of illiteracy, witnessed verbal informed consent with documentation of a thumbprint in lieu of a signature. - Passes Test of Understanding. - Man or woman aged 20-50 years. - Initiated on ART during acute HIV infection (Fiebig Stage I to III at RV 254 enrollment). - Prescribed ART for at least 24 months prior to enrollment. - HIV-1 RNA less than 50 copies/mL on at least three consecutive measurements within the past 12 months. - Integrated HIV DNA in peripheral blood mononuclear cells (PBMCs) below the level of detection (1 copy/10^5 PBMCs) within 6 months prior to enrollment. - Last documented peripheral blood CD4 greater than 400 cells/mm^3 within 3 months prior to enrollment. - No HIV-related or AIDS-defining illness within 6 months prior to enrollment. - In general good health. - Able to participate in study visits. 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 beta-human chorionic gonadotropin (ß-HCG) 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: - Previous receipt of humanized or human monoclonal antibody whether licensed or investigational. - Ongoing AIDS-related opportunistic infection (including oral thrush). - Active injection drug use within previous 12 months. - History of a severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis in the 2 years prior to enrollment. - History of chronic urticaria requiring daily treatment. - Physical finding on examination considered indicative of significant disease such as murmur (other than functional), hepatosplenomegaly, or focal neurologic deficit. - Hypertension that is not well controlled by medication. - Hepatitis B surface antigen positive at any time in the past. - Hepatitis C antibody positive at any time in the past. - Untreated syphilis. - Estimated glomerular filtration rate (GFR) less than 50 ml/min within the past 90 days. - Pregnant or breastfeeding. - Receipt of licensed vaccine or other investigational study agent within 28 days prior to enrollment or past participation in an investigational HIV vaccine study with receipt of active product. - Current or planned participation in another interventional clinical trial during the study period. - Chronic or recurrent use of medications that modify host immune response, e.g., oral or parenteral steroids, cancer chemotherapy. - Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer. Including, but not limited to: diabetes mellitus type I, chronic hepatitis, renal failure; OR clinically significant forms of: drug or alcohol abuse, mental illness, severe asthma, autoimmune disease, psychiatric disorders, heart disease, or cancer. - Study site employee. |
Country | Name | City | State |
---|---|---|---|
Thailand | SEARCH Thai Red Cross AIDS Research Centre Non-Network CRS | Bangkok |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Serious Adverse Event | Participants were monitored for up to 10 weeks after the last infusion of VRC01 or placebo | Measured up to 10 weeks after last infusion of VRC01 or placebo | |
Primary | Number of Participants With Sustained Virologic Suppression | Number of participants who sustained virologic control (HIV RNA <50 copies/mL), without indication for ART resumption at week 24. | Measured through 24 weeks after ATI | |
Secondary | Time to Viral Rebound After Cessation of ART | This is the days from Analytic Treatment Interruption (ATI) to: HIV RNA >= 20 copies/mL. HIV RNA >= 1000 copies/mL |
Measured from Baseline ATI through ART resumption. | |
Secondary | Level of Rebound Viremia After Cessation of ART | This is the HIV-1 RNA levels (copies/mL) at first detection and ART resumption. | Measured from Baseline ATI through ART resumption. | |
Secondary | Time to ART Resumption for Any Reason After Cessation of ART | This is the days from ATI to ART resumptions. | Measured from Baseline ATI through ART resumption. | |
Secondary | Number of Participants With Detectable HIV-1 RNA Via Single Copy Assay | This is number of participants who had detectable HIV-1 RNA via the ultrasensitive single copy assay prior to detectability on the routine assay. | Measured from Baseline ATI through ART resumption. | |
Secondary | Change in CD4+ T Cell Count From ATI to ART Resumption | This is change in CD4+ T cell count from ATI to ART resumption. | Measured from Baseline ATI through ART resumption | |
Secondary | Total HIV DNA in the Peripheral Compartment | This is total HIV DNA levels at baseline ATI, ART resumption and 6 month after ART resumption | Measured from ATI through 6 months after ART resumption | |
Secondary | Number of Participants Hospitalized. | Participants were monitored for up to 10 weeks after the last infusion of VRC01 or placebo | Measured up to 10 weeks after the last infusion of VRC01 or placebo | |
Secondary | Number of Participants With Acute Retroviral Syndrome (ARS) | This is the number of participants who have developed during ATI. | Measured from Baseline ATI through ART resumption. | |
Secondary | Neuropsychological Battery Performance | This is a NPZ-4 score,a 4-test NP battery evaluated fine motor function/manual dexterity [Grooved Pegboard test (GP), non-dominant hand], psychomotor speed [Color Trails 1 (CT1), Trail Making A (TM)], and executive function/set shifting [Color Trails 2 (CT2)]. Individual test raw scores were converted to z-scores. Z-scores range from -3 standard deviations up to +3 standard deviations. Higher scores indicate better test performance and lower cognitive impairment. | Measured from Baseline ATI through ART resumption. | |
Secondary | Computed Score on the Control and Attention Task (i.e., Flanker Task) | The Flanker is a measure of executive function, specifically tapping inhibitory control and attention.The scores range from 0 to 10. A higher scores indicate higher levels of ability to attend to relevant stimuli and inhibit attention from irrelevant stimuli. | Measured from Baseline ATI through ART resumption. |
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