HIV Infections Clinical Trial
Official title:
CID 0821 - Pilot Study to Evaluate HIV Viremia and Persistence in Acutely HIV-Infected Antiretroviral Naïve Patients Treated With Darunavir/Ritonavir and Etravirine
Purpose: This is a pilot study to evaluate HIV viremia and persistence in acutely HIV
infected antiretroviral naïve patients treated with Darunavir/ritonavir and Etravirine
Participants: 20 participants, age 18 and older, HIV infected, antiretroviral naïve patients
Procedures (methods): ARV treatment with Darunavir/ritonavir and Etravirine,
Optional studies:
Genital secretion samples, Cerebrospinal fluid samples, Leukapheresis, Endoscopy/colonoscopy
Study Design
This is a multicenter, single arm, 48-week open-label pilot study of DRV/R & ETR in acute HIV
infection. Study sites will be members of the Duke-UNC Acute HIV Infection Study Consortium.
If baseline resistance is detected after treatment begins (e.g. evidence of pre-existing
baseline resistance (genotypic or phenotypic) that may adversely affect the efficacy of the
study regimen), the patient may elect to alter treatment as per best clinical practice. The
new regimen will not be provided by the study, but will be obtained for the participant
through available clinical resources.
After patients are identified with acute HIV infection, they will be offered the opportunity
to participate in the study. Patients will also be offered the opportunity to co-enroll in
CHAVI 001 and 012, studies that follow the virological and immunological response of patients
with AHI, regardless of the initiation of ART. An overall consent form will be signed for
study participation, and separate informed consents with signatures will be obtained for
optional studies. Patients will be eligible for participation after signing the overall
consent - agreeing to participate in studies of other compartment specimens is not required
for enrollment. At the initial visit, patient eligibility will be confirmed with appropriate
laboratory testing (see "STUDY POPULATION"). When eligibility is verified, entry laboratory
studies will be obtained, and the participants will be started on DRV/r, and ETR. All
participants will be followed at regular intervals thereafter as specified in the schedule of
evaluations. Participants meeting criteria for virologic failure will be offered the
opportunity to switch to the best available regimen as selected by their HIV provider.
Hypothesis
Combination therapy with DRV/R & ETR will suppress plasma viremia and improve immunologic
function in antiretroviral (ART)-naïve, acutely HIV-infected (AHI) patients, and will limit
replication in HIV-1 cellular compartments.
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