CClinicalTrials.gg
Status unknownNCT03883334Updated Dec 23, 2019

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

A Phase 4 interventional study of Metisoprinol in HIV Infections, sponsored by Universidad San Francisco de Quito. Status unknown at 1 site in Ecuador. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-23.

Sponsored by Universidad San Francisco de Quito · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • HIV Infections

Browse trials for

03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's planned enrollment of 60 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Universidad San Francisco de Quito is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Immunomodulator group

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

    Drug: Metisoprinol

  • No intervention
    Control group

    combine antiretroviral therapy only

Interventions

  • DrugMetisoprinol

    Immunodulator

    Also known as: Isoprinosine

06

What researchers measure

Primary outcomes

  1. Viral load

    Number of viral copies/mL

    Time frame: Change from Baseline viral load at 3 months

Secondary outcomes

  1. CD4+ count

    Number of CD4+ cells

    Time frame: Change from Baseline CD4+ count at 3 months

07

Study locations

1 site
  • Hospital Enrique Garces
    Quito, 170901, Ecuador
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03883334
Lead sponsor
Universidad San Francisco de Quito
Responsible party
Enrique Teran (Professor, Universidad San Francisco de Quito) — Principal investigator
First posted
Mar 20, 2019
Start date
Feb 28, 2019
Primary completion
Mar 30, 2020 (estimated)
Completion
Jun 30, 2020 (estimated)
Last update
Dec 23, 2019

Study contacts

Enrique Teran, MD, PhD
study director · Universidad San Francisco de Quito

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion