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Trial record 48 of 1180 for:    "Observational" [STUDY-TYPES] AND HIV [CONDITION]

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

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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

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

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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
United States, Alabama
Alabama Vaccine CRS
Birmingham, Alabama, United States, 35294
United States, California
Bridge HIV CRS
San Francisco, California, United States, 94143
United States, Georgia
The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, United States, 30030
United States, Illinois
UIC Project WISH CRS
Chicago, Illinois, United States, 60612
United States, Massachusetts
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States, 02115-6110
Fenway Health Clinical Research Site CRS
Boston, Massachusetts, United States, 02215-4302
United States, New York
NY Blood Ctr./Union Square CRS
New York, New York, United States, 10003
Columbia P&S CRS
New York, New York, United States, 10032-3732
NY Blood Ctr./Bronx CRS
New York, New York, United States, 10455
University of Rochester Vaccines to Prevent HIV Infection CRS
New York, New York, United States, 14642
United States, Pennsylvania
Penn Prevention CRS
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, United States, 37232-2582
United States, Washington
Seattle Vaccine and Prevention CRS
Seattle, Washington, United States, 98109-1024
Dominican Republic
Unidad de Vacunas IDCP-COIN-DIGECITSS CRS
Santo Domingo, Dominican Republic
Haiti
Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
Port-au-Prince, Haiti, HT-6110
Peru
ACSA CRS
Iquitos, Maynas, Peru, 1
Puerto Rico
Maternal-Infant Studies Center (CEMI) CRS
San Juan, Puerto Rico, 00935
South Africa
Soweto HVTN CRS
Johannesburg, Gauteng, South Africa, 1862
eThekwini CRS
Durban, Kwa Zulu Natal, South Africa, 4013
Aurum Institute Klerksdorp CRS
Klerksdorp, North West Province, South Africa, 2571
Emavundleni CRS
Cape Town, Western Cape, South Africa, 7750
Sponsors and Collaborators
HIV Vaccine Trials Network
Investigators
Study Chair: Magdalena Sobieszcyk Columbia University

Responsible Party: HIV Vaccine Trials Network
ClinicalTrials.gov Identifier: NCT03337906     History of Changes
Other Study ID Numbers: HVTN 802
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017

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:
HIV Infections
Infection
Communicable Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs