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Sponsors and Collaborators: |
The University of North Carolina, Chapel Hill Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA |
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Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00855413 |
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
Condition | Intervention | Phase |
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Acute HIV Infection HIV Infections |
Drug: Darunavir/Ritonavir and Etravirine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
DRV/r will be administered 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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Calculated creatinine clearance (Cockcroft-Gault formula) > 30mL/min:
For women of reproductive potential, a negative serum or urine pregnancy test within 7 days prior to initiating antiretroviral study medications.
Reproductive potential is defined as females who have reached menarche and have not been post-menopausal for at least 24 consecutive months, or have not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or salpingotomy). Acceptable documentation of surgical sterilization includes patient-reported history.
Exclusion Criteria:
Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry.
Contact: JoAnn Kuruc | 919-966-8533 | joann_kuruc@med.unc.edu |
United States, North Carolina | |
The University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 | |
Duke University | |
Durham, North Carolina, United States, 27707 |
Principal Investigator: | Cynthia Gay, MD, MPH | The University of North Carolina, Chapel Hill |
Principal Investigator: | David M Margolis, MD | The University of North Carolina, Chapel Hill |
Responsible Party: | The University of North Carolina, Chapel Hill ( Cynthia Gay, MD, MPH ) |
Study ID Numbers: | CID 0821 |
Study First Received: | March 2, 2009 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00855413 History of Changes |
Health Authority: | United States: Institutional Review Board |
Acute HIV HIV Treatment Naive Acute Infections |
Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Darunavir Protease Inhibitors |
Virus Diseases Anti-Retroviral Agents HIV Infections Ritonavir Sexually Transmitted Diseases Viremia Retroviridae Infections |
Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Darunavir Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections RNA Virus Infections HIV Protease Inhibitors Anti-HIV Agents |
Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |