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

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.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03883334

Enrollment

Registered

2019-03-20

Start date

2019-02-28

Completion date

2020-06-30

Last updated

2019-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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.

Interventions

DRUGMetisoprinol

Immunodulator

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Viral load	Change from Baseline viral load at 3 months	Number of viral copies/mL

Secondary

Measure	Time frame	Description
CD4+ count	Change from Baseline CD4+ count at 3 months	Number of CD4+ cells

Countries

Ecuador

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026