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Efficacy of ART to Interrupt HIV Transmission Networks (ART-NET)

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ClinicalTrials.gov Identifier: NCT02528773
Recruitment Status : Recruiting
First Posted : August 19, 2015
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Susan Little, MD, University of California, San Diego

Brief Summary:
The investigators are conducting a study to learn more about the spread of HIV infection within different geographic regions and populations in San Diego County, with the goal of demonstrating that early use of HIV treatment can reduce the number of new infections in our community. At the study visits, participants will be examined by the study staff and asked to donate some blood. Participants will also be asked several questions about themselves, their background, behaviors, health, and the general geographic area in which they live. By collecting information about antiretroviral treatment choices that are made by study participants, the investigators will be better able to measure how effectively HIV treatment can interrupt (i.e., block) the spread of HIV. All of the information gathered at the study visits will be de-identified and analyzed. Study staff will use the information to better understand in which groups of people, and in what areas of San Diego, HIV is spreading most quickly. This information will be used to determine how well Antiretroviral Therapy (HIV treatment) by certain individuals can control the spread of HIV within the population.

Condition or disease
HIV

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Study Type : Observational
Estimated Enrollment : 425 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of ART to Interrupt HIV Transmission Networks
Study Start Date : October 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
HIV positive
Persons newly diagnosed with HIV.



Primary Outcome Measures :
  1. Network-level efficacy of ART as measured by the number of newly infected persons and network cluster growth over time [ Time Frame: 5 Years ]

Biospecimen Retention:   Samples With DNA

Blood Draws: Approximately 2 tablespoons (30 mL) of blood will be taken for blood tests and storage at each visit. Participants' blood will be tested for:

  • CD4+/CD8+ T-cell Count. This is a measure of the immune system; T-cells help the immune system fight infections.
  • HIV-1 RNA (Viral Load). This measures the amount of HIV in the blood.
  • HIV pol sequence. This measures the type of HIV in your blood.
  • Blood will be collected for storage for future HIV testing, studies to measure the amount of residual HIV that remains in people who are doing well on HIV treatment, genetic testing of the HIV virus and possible HLA genotype testing as determined by the results of this and future studies.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Persons with newly diagnosed HIV infection
Criteria

Inclusion Criteria:

  1. Age ≥18 years of age
  2. Newly diagnosed HIV infection
  3. ART naïve (≤7 days ART, previous use of PEP or PrEP are not exclusions)
  4. Subject must be able to provide written consent
  5. Subject must agree to study specific specimen collections and visit schedule.
  6. Subjects with newly diagnosed HIV infection who were identified on or after May 1, 2014 will be eligible for enrollment as long as they are co-enrolled to either AEH020 (project 08-0278) or AEH030 (project 140093) and DID meet the above study inclusion criteria (items at the time of enrollment to protocols AEH020 or AEH030).

Exclusion Criteria:

  1. Any factor or factors that in the opinion of the local investigator that could prevent compliance with study requirements.
  2. Contraindication to phlebotomy or specimen collection.

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): NCT02528773


Contacts
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Contact: Jill Kunkel, RN 6195438080 jkunkel@ucsd.edu

Locations
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United States, California
UCSD AntiViral Research Center Recruiting
San Diego, California, United States, 92103
Contact: Liliana Ramirez    619-543-8080    lir003@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Susan J Little, MD UCSD

Additional Information:
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Responsible Party: Susan Little, MD, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02528773     History of Changes
Other Study ID Numbers: 141105
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018