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

NCT03883334 | Unknown Phase 4

• 1 other identifier: HUBI - 12522
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Viral load

  Number of viral copies/mL

  Change from Baseline viral load at 3 months

Secondary Outcomes (1)

• CD4+ count

  Change from Baseline CD4+ count at 3 months

Study Arms (2)

Immunomodulator group

EXPERIMENTAL

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

Drug: Metisoprinol

Control group

NO INTERVENTION

combine antiretroviral therapy only

Interventions

Metisoprinol DRUG

Immunodulator

Also known as: Isoprinosine

Immunomodulator group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad San Francisco de Quito: lead

Study Sites (1)

Hospital Enrique Garces

Quito, 170901, Ecuador

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Inosine Pranobex

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Enrique Teran, MD, PhD

  Universidad San Francisco de Quito

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: March 20, 2019
• Study Start: February 28, 2019
• Primary Completion: March 30, 2020
• Study Completion: June 30, 2020
• Last Updated: December 23, 2019

Record last verified: 2019-12

Locations

EC (1)