Clinical trial NCT03337906: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
Lead sponsor: HIV Vaccine Trials Network
Sponsor class: NETWORK
First posted: 2017-11-09
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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

Eligibility 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.)

Primary outcomes:
measure: Measure plasma HIV-1 RNA levels and CD4+ T cell counts longitudinally
timeFrame: 8 years
measure: Measure time to initiation of ART
timeFrame: 8 years
measure: Measure time to HIV-1 related clinical events
timeFrame: 8 years
measure: Proportion of individuals with plasma HIV-1 RNA level <50 copies/mL at 24 weeks after initiation of ART
timeFrame: 8 years
Secondary outcomes:
measure: Time from initiation of ART to treatment failure due to virologic, immunologic, and clinical reasons
timeFrame: 8 years
measure: Occurrence of HIV/AIDS associated events, including death
timeFrame: 8 years
measure: 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
timeFrame: 24, 48, 96, and 144 weeks
measure: Adherence information collected at 24, 48, 96, and 144 weeks following initiation of ART
timeFrame: 24, 48, 96, and 144 weeks
measure: Side effects collected at 24, 48, 96, and 144 weeks following initiation of ART
timeFrame: 24, 48, 96, and 144 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Vaccine CRS
state: Alabama
city: San Francisco
country: United States
facility: Bridge HIV CRS
state: California
city: Decatur
country: United States
facility: The Hope Clinic of the Emory Vaccine Center CRS
state: Georgia
city: Chicago
country: United States
facility: UIC Project WISH CRS
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
state: Massachusetts
city: Boston
country: United States
facility: Fenway Health Clinical Research Site CRS
state: Massachusetts
city: New York
country: United States
facility: NY Blood Ctr./Union Square CRS
state: New York
city: New York
country: United States
facility: Columbia P&S CRS
state: New York
city: New York
country: United States
facility: NY Blood Ctr./Bronx CRS
state: New York
city: New York
country: United States
facility: University of Rochester Vaccines to Prevent HIV Infection CRS
state: New York
city: Philadelphia
country: United States
facility: Penn Prevention CRS
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Vaccine (VV) CRS
state: Tennessee
city: Seattle
country: United States
facility: Seattle Vaccine and Prevention CRS
state: Washington
city: Santo Domingo
country: Dominican Republic
facility: Unidad de Vacunas IDCP-COIN-DIGECITSS CRS
city: Port-au-Prince
country: Haiti
facility: Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
city: Iquitos
country: Peru
facility: ACSA CRS
state: Maynas
city: San Juan
country: Puerto Rico
facility: Maternal-Infant Studies Center (CEMI) CRS
city: Johannesburg
country: South Africa
facility: Soweto HVTN CRS
state: Gauteng
city: Durban
country: South Africa
facility: eThekwini CRS
state: Kwa Zulu Natal
city: Klerksdorp
country: South Africa
facility: Aurum Institute Klerksdorp CRS
state: North West Province
city: Cape Town
country: South Africa
facility: Emavundleni CRS
state: Western Cape
Study officials:
affiliation: Columbia University
name: Magdalena Sobieszcyk
role: STUDY_CHAIR
References: