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

Phase 4

• Conditions: HIV Infections
• Interventions: Drug: Metisoprinol

• Registration Number: NCT03883334
• Lead Sponsor: Universidad San Francisco de Quito

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-07
• Study Start: 2019-02-28
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-20
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-19
• Last Update Posted: 2019-12-23
• Primary Completion: 2020-03-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immunomodulator group	Metisoprinol	Metisoprinol 1 gr every 8 h per ten days during three months plus the combine antiretroviral therapy.

Primary Outcome Measures

Name	Time	Method
Viral load	Change from Baseline viral load at 3 months	Number of viral copies/mL

Secondary Outcome Measures

Name	Time	Method
CD4+ count	Change from Baseline CD4+ count at 3 months	Number of CD4+ cells

Trial Locations

Locations (1)

Hospital Enrique Garces; 🇪🇨 Quito, Ecuador