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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03883334
Other study ID # HUBI - 12522
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date February 28, 2019
Est. completion date June 30, 2020

Study information

Verified date December 2019
Source Universidad San Francisco de Quito
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date June 30, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Metisoprinol
Immunodulator

Locations

Country Name City State
Ecuador Hospital Enrique Garces Quito

Sponsors (1)

Lead Sponsor Collaborator
Universidad San Francisco de Quito

Country where clinical trial is conducted

Ecuador, 

Outcome

Type Measure Description Time frame Safety issue
Primary Viral load Number of viral copies/mL Change from Baseline viral load at 3 months
Secondary CD4+ count Number of CD4+ cells Change from Baseline CD4+ count at 3 months
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