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

NCT ID: NCT03883334

Last Updated: 2019-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2020-06-30

Brief Summary

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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

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immunomodulator group

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

Group Type EXPERIMENTAL

Metisoprinol

Intervention Type DRUG

Immunodulator

Control group

combine antiretroviral therapy only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Metisoprinol

Immunodulator

Intervention Type DRUG

Other Intervention Names

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Isoprinosine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad San Francisco de Quito

OTHER

Sponsor Role lead

Responsible Party

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Enrique Teran

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enrique Teran, MD, PhD

Role: STUDY_DIRECTOR

Universidad San Francisco de Quito

Locations

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Hospital Enrique Garces

Quito, , Ecuador

Site Status

Countries

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Ecuador

Other Identifiers

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HUBI - 12522

Identifier Type: -

Identifier Source: org_study_id