Isoprinosine in HIV Patients With Viral Load > 50 y < 200 Copies/mL

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03883334
• Other study ID #: HUBI - 12522
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 28, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: December 2019
• Source: Universidad San Francisco de Quito
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Metisoprinol
Immunodulator

Locations

Country	Name	City	State
Ecuador	Hospital Enrique Garces	Quito

Sponsors (1)

Lead Sponsor	Collaborator
Universidad San Francisco de Quito

Country where clinical trial is conducted

Ecuador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral load	Number of viral copies/mL	Change from Baseline viral load at 3 months
Secondary	CD4+ count	Number of CD4+ cells	Change from Baseline CD4+ count at 3 months