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Proviral DNA as a Target for HIV-1 Resistance Analysis (HIV)

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ClinicalTrials.gov Identifier: NCT04088916
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
PABLO ANDRES FERRER CAMPOS, University of Chile

Brief Summary:

In summary, in this project the investigators propose to study the proviral DNA genotyping to implement a lower cost and wider than the commercial systems currently in use, in order to analyze all HIV genes that are therapeutic targets of antiretroviral drugs. Using HIV proviral DNA we can obtain information for: HIV-1 Viral Tropism, Mutations associated to Integrase Inhibitors, Mutations associated to Transcriptase reverse Inhibitors, Mutations associated to Protease Inhibitors, and Mutations associated to GP41 Inhibitors.

Along with this the investigators propose to validate the proviral DNA as starting material for genotyping which is independent of the patient's viral load and achieve a greater number of patients living with HIV have access to this important test that is essential in monitoring the HIV infection.

3.2 RESEARCH QUESTIONs Is proviral DNA a genetic compartment suitable for carrying out a genotypic resistance test in patients with low or undetectable viral load? Does proviral DNA have the same clinical validity that RNA? 3.3.- HYPOTHESIS A resistance genotyping test carried out by Proviral DNA detects the same mutations associated to resistance that viral RNA.

3.4.- OBJECTIVES: General/Specific General objective Develop a methodology to assess the proviral HIV-1 DNA or RNA as the genetic material for genotyping assays in genes that are targets of pharmacological interest as TR reverse transcriptase and protease (PRO), Integrase or GP41 Inhibitors and HIV tropism. Specific Objectives

1. Carry out genotyping by proviral DNA and compare it with the same genes genotyping performed with viral RNA. 2. Once the correlation between proviral DNA and RNA has shown, standardize a method to use the technique for clinical use in monitoring HIV patients according to each patient's needs. RNA for patients with viral load above 1,000 copies/mL. Proviral DNA for patients with low or undetectable viral load.


Condition or disease
HIV/AIDS HIV Infections HIV Seropositivity Viral Infection

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Proviral DNA as a Target for HIV-1 Resistance Analysis
Actual Study Start Date : October 15, 2018
Actual Primary Completion Date : September 8, 2019
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. Proviral DNA as a Target for HIV-1 Resistance Analysis [ Time Frame: 3 years ]
    Develop a methodology to assess the proviral HIV-1 DNA or RNA as the genetic material for genotyping assays in genes that are targets of pharmacological interest as TR reverse transcriptase and protease (PRO), Integrase or GP41 Inhibitors and HIV tropism


Biospecimen Retention:   Samples With DNA
HIV ADN proviral


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Inclusion/Exclusion: Our Study will include only patients with HIV that had been confirmed by "Instituto de Salud Pública de Chile" (ISP-Chile). Children less than 18 years are excluded.

Number of Patients: A total of 1,200 patients will be included in a period of three years (Including statistical justification, if appropriate)

Criteria

Inclusion Criteria:

Clinical diagnosis of HIV

viral load <1.000 copies/mL

under antiretroviral tratment

Exclusion Criteria:

HIV negative

viral load >1.000 copies/mL


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088916


Locations
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Chile
Immunology, HIV and Allergy Section Recruiting
Santiago, Metropolitana, Chile
Contact: pablo ferrer, phd    +56950269199    pferrer@hcuch.cl   
Molecular Medicine Laboratory Recruiting
Santiago, Metropolitana, Chile
Contact: pablo ferrer, phd    +56950269199    pferrer@hcuch.cl   
Sponsors and Collaborators
University of Chile
ViiV Healthcare
Investigators
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Principal Investigator: Pablo Ferrer, Dr Hospital Clínico Universidad de Chile

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Responsible Party: PABLO ANDRES FERRER CAMPOS, Assistant Professor, University of Chile
ClinicalTrials.gov Identifier: NCT04088916     History of Changes
Other Study ID Numbers: Nº OAIC 986/18
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PABLO ANDRES FERRER CAMPOS, University of Chile:
ADNproviral
HIV
Resistance
genotyping
Additional relevant MeSH terms:
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Infection
Communicable Diseases
HIV Seropositivity
Virus Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases