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

Universidad San Francisco de Quito

Status and phase: Unknown; Phase 4

Conditions: HIV Infections

Treatments: Drug: Metisoprinol

Study type: Interventional

Funder types: Other

Identifiers

NCT03883334

HUBI - 12522

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Immunomodulator group

Experimental group

Description:

Metisoprinol 1 gr every 8 h per ten days during three months plus the combine antiretroviral therapy.

Treatment:

Drug: Metisoprinol

Control group

No Intervention group

Description:

combine antiretroviral therapy only