Isoprinosine in HIV Patients With Viral Load > 50 y < 200 Copies/mL
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Phase 4
Locations
Ecuador
Study Type
Interventional
Intervention
Metisoprinol
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility Criteria
Inclusion Criteria:
- Older than 18 years old.
- Patients with a viral load (RNA of VIH) between > 50 and < 200 copies/mL after 24 weeks of antiviral therapy or after scheme change.
- Informed consent signature
Exclusion Criteria:
- Younger than 18 years old.
- No virologic failure or RNA of VIH > 200 copies/mL.
- Presence of a serious opportunistic infection.
- Renal failure (including litiasis) or presence of gout.
- Pregnancy.
Sites / Locations
- Hospital Enrique Garces
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Immunomodulator group
Control group
Arm Description
Metisoprinol 1 gr every 8 h per ten days during three months plus the combine antiretroviral therapy.
combine antiretroviral therapy only
Outcomes
Primary Outcome Measures
Viral load
Number of viral copies/mL
Secondary Outcome Measures
CD4+ count
Number of CD4+ cells
Full Information
NCT ID
NCT03883334
First Posted
February 7, 2019
Last Updated
December 19, 2019
Sponsor
Universidad San Francisco de Quito
1. Study Identification
Unique Protocol Identification Number
NCT03883334
Brief Title
Isoprinosine in HIV Patients With Viral Load > 50 y < 200 Copies/mL
Official Title
Efecto de la Isoprinosina en Pacientes Con infección Por VIH y Carga Viral Entre > 50 y < 200 Copias/mL de la Unidad de atención de PVV Del Hospital Enrique Garcés en Quito, Ecuador Durante el año 2019.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
March 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad San Francisco de Quito
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Virological failure is a complication of treatment in patients with HIV, and it can be as high as 42% to first line treatment or around 18% in second line treatment. The reasons behind this phenomenon are several, including adherence to treatment (self-patient) or those related to the drugs (kinetics, interactions) and the virus itself (resistance patterns). People living with HIV needs treatment for all their lives, another factor to facilitate virus resistance and poor adherence to treatment. For that reason, it is necessary to look for additional therapeutic options to minimize this problem, and the use of immunomodulatory drugs is an interesting topic now. Among those drugs, isoprinosine hs been reported not only improve the immune response, it also has the capability to inhibit the replication of RNA virus. Then, we propose an open label clinical trial to evaluate the effect of isoprinosine in HIV patients with a virological load between 50 and 200 copies/ml.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immunomodulator group
Arm Type
Experimental
Arm Description
Metisoprinol 1 gr every 8 h per ten days during three months plus the combine antiretroviral therapy.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
combine antiretroviral therapy only
Intervention Type
Drug
Intervention Name(s)
Metisoprinol
Other Intervention Name(s)
Isoprinosine
Intervention Description
Immunodulator
Primary Outcome Measure Information:
Title
Viral load
Description
Number of viral copies/mL
Time Frame
Change from Baseline viral load at 3 months
Secondary Outcome Measure Information:
Title
CD4+ count
Description
Number of CD4+ cells
Time Frame
Change from Baseline CD4+ count at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Older than 18 years old.
Patients with a viral load (RNA of VIH) between > 50 and < 200 copies/mL after 24 weeks of antiviral therapy or after scheme change.
Informed consent signature
Exclusion Criteria:
Younger than 18 years old.
No virologic failure or RNA of VIH > 200 copies/mL.
Presence of a serious opportunistic infection.
Renal failure (including litiasis) or presence of gout.
Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Teran, MD, PhD
Organizational Affiliation
Universidad San Francisco de Quito
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Enrique Garces
City
Quito
ZIP/Postal Code
170901
Country
Ecuador
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Isoprinosine in HIV Patients With Viral Load > 50 y < 200 Copies/mL
We'll reach out to this number within 24 hrs