A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada for Pre-Exposure Prophylaxis (PrEP)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-series

Study drug and medical condition

• Medical condition to be studied:
  Prophylaxis against HIV infection

Population studied

• Short description of the study population:
  HIV-1 negative adults or adolescents (any sex/gender, including transgender) who developed new HIV-1 infection (i.e., seroconverted) while taking Truvada for PrEP.; To be eligible for inclusion in this data analysis, an individual must satisfy all of the following criteria:; 1. Evidence of new HIV-1 infection after initiating Truvada for PrEP; 2. Individuals may have received Truvada for PrEP from demonstration project or Truvada for; 3. PrEP clinical study or they may have received Truvada for PrEP as described in spontaneous or literature reports, always with accompanying results of resistance testing; Exclusion Criteria:; 1. Spontaneous or literature report without results of resistance testing
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  150

Study design details

• Main study objective:
  This study evaluated HIV-1 RNA and the presence or absence of resistance at baseline and following seroconversion, assessed the frequency of HIV-1 screening and screening method(s) used for evaluation of seroconverters, and collected information regarding whether the seroconverter experienced signs and symptoms of acute HIV-1 infection prior to or at the time of seroconversion.
• Outcomes:
  The objectives of the study were to evaluate HIV-1 RNA and the presence or absence of resistance at baseline and following seroconversion, assess the frequency of HIV-1 screening and screening method(s) used for evaluation of seroconverters, and collect information regarding whether the seroconverter experienced signs and symptoms of acute HIV-1 infection prior to or at the time of seroconversion.
• Data analysis plan:
  GS-US-276-0103 collected and analyzed data from individuals who took Truvada® for pre-exposure prophylaxis (PrEP) of sexually acquired HIV-1 infection and who seroconverted (become HIV-1 positive) during follow up. For a minimum of 150 seroconverters, data described: 1) the presence or absence of signs and symptoms of acute HIV infection at the study visit or since the last study visit when seroconversion was identified, 2) the frequency of screening and screening method(s) used for evaluation of the seroconverter, and in general, at that enrollment site, 3) baseline samples from early seroconverters to evaluate HIV-1 RNA and the presence or absence of resistance, and 4) resistance analyses of viral isolates from seroconverters that include population nucleotide sequence analysis followed by ultrasensitive testing (such as ultra-deep sequencing of proviral DNA or allele-specific PCR) if no resistance is identified by population sequencing.

Documents

Study results

GS-US-276-0103-Final-CSR_f-redact