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An Observational Study of Long-term Outcomes of HIV-1 Infection in Persons Who Become HIV-1 Infected After Enrollment in HIV-1 Vaccine Trials

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03337906
Recruitment Status : Completed
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
HIV Vaccine Trials Network

Brief Summary:
An observational study of long-term outcomes of HIV-1 infection in persons who become infected after enrollment in HIV-1 vaccine trials

Condition or disease Intervention/treatment
HIV Infections Other: Observation

Detailed Description:
A descriptive and observational study of long-term outcomes of HIV-1 infection in persons who become HIV-1 infected after enrollment in HIV-1 vaccine trials

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Study Type : Observational
Actual Enrollment : 209 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Descriptive and Observational Study of Long-term Outcomes of HIV-1 Infection in Persons Who Become HIV-1 Infected After Enrollment in HIV-1 Vaccine Trials
Actual Study Start Date : July 11, 2008
Actual Primary Completion Date : July 11, 2015
Actual Study Completion Date : July 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
Participants infected with HIV-1
Persons who become HIV-1 infected after enrollment in HIV-1 vaccine trials
Other: Observation



Primary Outcome Measures :
  1. Measure plasma HIV-1 RNA levels and CD4+ T cell counts longitudinally [ Time Frame: 8 years ]
  2. Measure time to initiation of ART [ Time Frame: 8 years ]
  3. Measure time to HIV-1 related clinical events [ Time Frame: 8 years ]
  4. Proportion of individuals with plasma HIV-1 RNA level <50 copies/mL at 24 weeks after initiation of ART [ Time Frame: 8 years ]

Secondary Outcome Measures :
  1. Time from initiation of ART to treatment failure due to virologic, immunologic, and clinical reasons [ Time Frame: 8 years ]
  2. Occurrence of HIV/AIDS associated events, including death [ Time Frame: 8 years ]
  3. Proportion of subjects with HIV-1 RNA level <50 copies/mL post-initiation of ART; log change in plasma HIV-1 RNA levels and change in CD4+ T cell levels between baseline (at initiation of ART) and post-initiation of ART [ Time Frame: 24, 48, 96, and 144 weeks ]
  4. Adherence information and side effects collected at 24, 48, 96, and 144 weeks following initiation of ART [ Time Frame: 24, 48, 96, and 144 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Both vaccine and placebo recipients in HVTN trials in which HIV infection constitutes an endpoint (eg, test-of-concept, phase 2 and 3) who become HIV-1 infected after enrollment in the parent study and who meet the inclusion criteria may be offered enrollment in the study.
Criteria

Inclusion Criteria:

  • Participants must meet the following criteria in order to be eligible for inclusion in the study:

    1. Confirmation of HIV-1 infection after enrollment in an HVTN vaccine trial in which HIV-1 infection constituted an endpoint, according to the diagnostic algorithm specified in the parent protocol.
    2. Ability and willingness to provide written informed consent to participate in the study.
    3. Ability and willingness to adhere to the on-study follow-up schedule.
    4. Ability and willingness to provide adequate information for locator purposes.
    5. Participants who are currently on ART or who previously received antiretrovirals as part of post-exposure prophylaxis, pre-exposure prophylaxis, or previous treatment regimen will be eligible for inclusion in this protocol. Their previous treatment history will be collected. If a participant has been on ART for more than 2 years, please consult with the protocol team leadership prior to enrollment.
    6. For participants initiating ART, agreement of participant and PHCP to initiate potent and durable ART regimens in accordance with local and international guidelines. Examples of potent and durable regimens are provided in Appendix H. Participants who initiate ART not consistent with regimens outlined in Appendix H may enroll with permission of the protocol chair or designee(s).

      Exclusion Criteria:

  • Persons who meet the following criteria will be excluded from the study:

    1. Any medical, psychiatric, alcohol/drug dependency or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or a participant's ability to give informed consent.
    2. Participants who meet these additional criteria will be excluded from the study:
  • Participants undergoing acute therapy for serious medical illnesses (in the opinion of the site investigator) within 14 days prior to initiation of ART.
  • Participants with chronic, acute, or recurrent infections that are serious (in the opinion of the site investigator).
  • Participants who must continue with chronic (maintenance) therapy (e.g., tuberculosis [TB], pneumocystis pneumonia [PCP]), must have completed at least 14 days of therapy and be clinically stable prior to initiation of ART.
  • Oral and vaginal candidiasis, mucocutaneous herpes simplex, and other minor illnesses, as defined by the site investigator, present no restriction to eligibility.
  • Participants undergoing radiation therapy, systemic chemotherapy, or receiving an immunomodulator within 45 days prior to initiation of ART. (A tapering course of corticosteroids as acute therapy for PCP or other conditions is an exception.)

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): NCT03337906


Locations
Show Show 21 study locations
Sponsors and Collaborators
HIV Vaccine Trials Network
Investigators
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Study Chair: Magdalena Sobieszcyk Columbia University
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Responsible Party: HIV Vaccine Trials Network
ClinicalTrials.gov Identifier: NCT03337906    
Other Study ID Numbers: HVTN 802
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017

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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 HIV Vaccine Trials Network:
HIV
Additional relevant MeSH terms:
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Infection
Communicable Diseases