Clinical trial NCT00855413
Conditions: Acute HIV Infection HIV Infections
Keywords: Acute HIV HIV Treatment Naive Acute Infections
Sponsor: University of North Carolina, Chapel Hill
Start date: 2009-03-01; Completion date: 2013-11-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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

Detailed description:
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.

Arms: arm 1: Darunavir/Ritonavir 800 mg/100 mg orally once daily.

ETR will be given 200 mg orally twice daily, although patients may choose to take ETR 400 mg QD to have a simpler all QD regimen.
Interventions: intervention 1: Darunavir intervention 2: Ritonavir intervention 3: Etravirine
Intervention descriptions: intervention 1: 800 mg orally once daily intervention 2: 100 mg orally once daily intervention 3: 200 mg orally twice daily, although patients may choose to take ETR 400 mg QD to have a simpler all QD regimen

Protocol documents: