Study to Evaluate HIV Viremia and Persistence in Acutely HIV-Infected ARV Naïve Patients Treated With Darunavir/Ritonavir and Etravirine
University of North Carolina, Chapel Hill
Information provided by (Responsible Party)
Cynthia L Gay, MD, University of North Carolina, Chapel Hill
First received: March 2, 2009
Last updated: October 14, 2014
Last Verified: October 2014
History of Changes
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,
Genital secretion samples, Cerebrospinal fluid samples, Leukapheresis, Endoscopy/colonoscopy
Acute HIV Infection
Drug : Darunavir/Ritonavir and Etravirine
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
Further study details as provided by Cynthia L Gay, MD, University of North Carolina, Chapel Hill:
Primary Outcome Measures
- To measure virologic and immunologic response in AHI with DRV/R & ETR (absolute values and change from baseline, plus slope of change). [ Time Frame: 48 weeks ]
- To measure drug levels in various compartments with replication in cellular compartments and immunological outcome. [ Time Frame: 48 weeks ]
|Study Start Date:||March 2009|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Darunavir/Ritonavir and Etravirine
Darunavir/Ritonavir and Etravirine 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.
Darunavir/Ritonavir and Etravirine
Other Name: Prezista, Norvir, Intelence
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.
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|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Documentation of Acute HIV Infection as defined above.
- Men and women age ≥18 years.
- Participants will be ART naïve, defined as ≤14 days of antiretroviral treatment at any time prior to entry. The only exceptions are: Post-exposure prophylaxis (PEP) provided the patient was documented as HIV-1 negative at least 3-6 months after completion of the PEP treatment.
- Screening HIV-1 RNA >1,000 copies/mL obtained within 30 days at study entry.
- Lab values obtained within 30 days prior to study entry:
- Absolute neutrophil count >500/mm3
- Hemoglobin > 8.5 g/dL for men and > 8.0 g/dL for women
- Platelet count >50,000/mm3
- AST (SGOT) ≤2.5 x ULN
- ALT (SGPT) ≤2.5 x ULN
- Total bilirubin <2.5 x ULN
- Calculated creatinine clearance (Cockcroft-Gault formula) > 30mL/min:
- CrCl = (140-age) x body weight (kg) (x 0.85 if female)
- Serum creatinine [mg/dL] x (72)
- 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.
- If participating in sexual activity that could lead to pregnancy, female study patients must use at least one form of contraception, which could consist only of a barrier method. All patients must continue to use contraception for 6 weeks after stopping the study medications. Acceptable methods of contraception include: condoms (male or female) with or without spermicidal agent, diaphragm or cervical cap with spermicide, or IUD. Female volunteers not of reproductive potential are not required to use contraception.
- Ability and willingness of patient to give written informed consent.
- Prednisone at a daily dose of 10 mg or less (physiologic replacement dose) is permitted.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855413
Locations Show More
|United States, North Carolina|
|The University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Durham, North Carolina, United States, 27707|
Sponsors and CollaboratorsUniversity of North Carolina, Chapel Hill
|Principal Investigator:||Cynthia Gay, MD, MPH||University of North Carolina, Chapel Hill|
|Principal Investigator:||David M Margolis, MD||University of North Carolina, Chapel Hill|
|Responsible Party:||Cynthia L Gay, MD, Clinical Assistant Professor, University of North Carolina, Chapel Hill|
|ClinicalTrials.gov Identifier:||NCT00855413 History of Changes|
|Other Study ID Numbers:||CID 0821|
|Study First Received:||March 2, 2009|
|Last Updated:||October 14, 2014|
Keywords provided by Cynthia L Gay, MD, University of North Carolina, Chapel Hill:Acute HIV
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.