Acute HIV InfectionPhase 4NCT00855413
HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine
A Phase 4 study testing Darunavir, Ritonavir and Etravirine in people with Acute HIV Infection and HIV Infections, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute HIV Infection, HIV Infections
- What is being tested?
- Darunavir, Ritonavir and Etravirine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2009to Nov 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Women who are pregnant or breast-feeding.
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- Women of reproductive potential who are unwilling or unable to use acceptable methods to avoid pregnancy for the entire study period
- Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry.
- Prednisone at a daily dose of 10 mg or less (physiologic replacement dose) is permitted.
- Known allergy/sensitivity to study drugs or their formulations.
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- Difficulty swallowing capsules/tablets.
- Inability to communicate effectively with study personnel.
- Incarceration; prisoner recruitment and participation are not permitted.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements or confound the analysis of study endpoints.
- Any active psychiatric illness including schizophrenia, severe depression, or severe bipolar affective disorder that, in the opinion of the investigator, could confound the analysis of the neurological examination or neuropsychological test results.
- Active brain infection (except for HIV-1), brain neoplasm, space-occupying brain lesion requiring acute or chronic therapy. Participants with any fungal meningitis, parasitic infection, or CNS lymphoma are excluded from participation.
- Serious illness requiring systemic treatment and/or hospitalization until patient either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry. NOTE: Oral candidiasis, vaginal candidiasis, mucocutaneous herpes simplex, and other minor illnesses (as judged by the site investigator) have no restriction.
- Known cardiac conduction disease.
- Prior treatment with any other experimental drug for any indication (within 30 days of initiating study treatment).
- Unable to discontinue any current medications that are excluded during study treatment.
- A life expectancy less than twelve months.
- Acute Viral Hepatitis, including, but not limited to, Hepatitis A, B, or C
- Chronic Hepatitis B Infection documented by a detectable serum Hepatitis B surface antigen (HBsAg) or plasma HBV DNA
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Duke University
Durham, North Carolina, 27707
About this 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
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
Read the 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.
- Conditions
- Acute HIV Infection, HIV Infections
- Being tested
- Darunavir, Ritonavir, Etravirine
- Keywords
- Acute HIV, HIV, Treatment Naive, Acute Infections
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarunavirDrug
Also called Prezista
800 mg orally once daily
RitonavirDrug
Also called Norvir
100 mg orally once daily
EtravirineDrug
Also called Intelence
200 mg orally twice daily, although patients may choose to take ETR 400 mg QD to have a simpler all QD regimen
| Study group | Role | What they receive |
|---|---|---|
| Darunavir/Ritonavir and Etravirine | Other | 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. Receives: Drug: Darunavir; Drug: Ritonavir; Drug: Etravirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Virologic Response
Virologic response defined as plasma HIV RNA measurement <200 copies/mL at week 24
Measured: 24 weeks
Secondary outcomes (37)
Number of Participants With Virologic Response
Virologic response to study treatment defined as plasma HIV RNA measurement <50 copies/mL at week 48
Measured: 48 weeks from enrollment
Median Change in CD4 Cell Count From Week 0 to Week 24.
Measured: week 0, week 24
Median Change in CD4 Cell Count From Week 0 to Week 48.
Measured: 48 weeks from enrollment
HIV RNA Levels Immediately Prior to Initiating Study Treatment.
Measured: HIV RNA level at enrollment
Median Time to HIV RNA Suppression to <200 Copies/mL
Measured: From enrollment to the date of HIV RNA suppression, assessed up to Week 48
HIV RNA Detection in Semen
Total cumulative levels of HIV RNA detected in the semen of participants from enrollment through week 48.
Measured: From enrollment through 48 weeks
Number of Participants Who Stopped Study Treatment Due to Adverse Event or Intolerance
Measured: Enrollment to Week 48
Adverse Events Possibly or Definitely Related to Study Treatment Through Week 48
Total number of adverse events observed that were possibly or definitely related to study treatment through week 48
Measured: Enrollment to week 48
Maximum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Measured: Week 4 and week 48
Minimum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Measured: Week 4 and week 48
Maximum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Measured: Week 4 and week 48
Minimum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Measured: Week 4 and week 48
Maximum Ritonavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Measured: Week 4 and Week 48
Minimum Ritonavir Exposure Range in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Measured: Week 4 and week 48
Maximum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen
Measured: Weeks 0-4 and weeks 12, 48
Minimum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen
Measured: Weeks 0-4 and weeks 12, 48
Maximum Darunavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen
Measured: Weeks 0-4 and weeks 12, 48
Minimum Darunavir Exposure Range in Semen Among Participants Who Consented to an Optional Collection of Semen
Measured: Weeks 0-4 and weeks 12, 48
Maximum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen
Measured: Weeks 0-4 and Weeks 12, 48
Minimum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen
Measured: Weeks 0-4 and Weeks 12, 48
Maximum Etravirine Exposure in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Measured: between Week 4-12 and between Weeks 36-48
Minimum Etravirine Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Measured: between Week 4-12 and between Weeks 36-48
Maximum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Measured: between Week 4-12 and between Weeks 36-48
Minimum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Measured: between week 4-12 and between weeks 36-48
Maximum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Measured: between week 4-12 and between Weeks 36-48
Minimum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Measured: between week 4-12 and between weeks 36-48
Number of Participants With HIV RNA Measurement Above the Limits of Detection in Cerebrospinal Fluid
Measured: Week 4 and Week 48
Number of Participants With Neurocognitive Impairment at Baseline
Measured: Week 2 or 4
Number of Participants With Neurocognitive Impairment at Week 24
Measured: Week 24
Number of Participants With Neurocognitive Impairment at Week 48
Measured: Week 48
Overall Neurocognitive Impairment Score at Week 2 or 4
Neuropsychological performance was assessed at Week 2 or 4, Week 24 and Week 48 in the following measures: Premorbid/language (Wide Range Achievement Test 4 -Reading Subtest), Learning (HVLT-R, Hopkins Verbal Learning Test-Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score was created by averaging all tests. Participants also completed the self-reported functional status Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.
Measured: Week 2 or 4
Overall Neurocognitive Impairment at Week 24
Neuropsychological performance was assessed at week 2 or 4, week 24 and week 48 in the following measures: Premorbid/language (Wide Range Achievement Test 4 -Reading Subtest), Learning (Hopkins Verbal Learning Test - Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score of neurocognitive functioning was created by averaging all tests. Participants also completed Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.
Measured: Week 24
Overall Neurocognitive Impairment at Week 48
Neuropsychological performance was assessed at baseline (week 2 or 4), week 24 and week 48 in the following domain (measures): Premorbid/language (Wide Range Achievement Test (WRAT) 4 - Reading Subtest), Learning (HVLT-R, Hopkins Verbal Learning Test - Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score of neurocognitive functioning was created by averaging all tests. Participants also completed the self-reported functional status Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.
Measured: Week 48
Change in Overall Neurocognitive Impairment From Baseline to Week 24 or 48
Change in overall z score from baseline to week 24 or 48. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.
Measured: Baseline to Week 24 or 48
Correlation of HIV RNA Levels in CSF and Drug Levels With Neurocognitive Functioning
Measured: From enrollment through Week 48
Correlation of Time to HIV RNA Levels <200 Copies/mL With Improvement in Neurocognitive Functioning From Baseline to Week 24 and 48
Measured: Baseline to Week 24 and 48
HIV RNA Detection in Ileal Biopsy Specimens
Average HIV RNA detected in the ileal biopsy specimens per participant over weeks 4 and 48.
Measured: Weeks 4 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Study halted by sponsor due to slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Responsible party
- Principal investigator, Cynthia L Gay, MD, University of North Carolina, Chapel Hill
- Investigators
- Cynthia Gay, MD, MPH, Principal investigator, University of North Carolina, Chapel HillDavid M Margolis, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855413
- Sponsor's protocol ID
- CID 0821
- Status last verified
- Sep 2017
- First submitted
- 2 Mar 2009
- Last updated
- 17 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gay CL, Mayo AJ, Mfalila CK, Chu H, Barry AC, Kuruc JD, McGee KS, Kerkau M, Sebastian J, Fiscus SA, Margolis DM, Hicks CB, Ferrari G, Eron JJ; Duke-UNC Acute HIV Infection Consortium. Efficacy of NNRTI-based antiretroviral therapy initiated during acute HIV infection. AIDS. 2011 Apr 24;25(7):941-9. doi: 10.1097/QAD.0b013e3283463c07.
PubMed 21487250C Gay, O Dibben, A Stacey, N Gasper-Smith, M Liu, N Goonetilleke, G Ferrari, J Eron, C Hicks, A McMichael, B Haynes, P Borrow, M Cohen, the Duke-UNC CHAVI 001 Clinical Working Group. "Effect(s) of antiretroviral treatment on acute HIV infection." XVII International AIDS Conference, 2008 Abstract no. THPE0086.
Gay CL, Neo DT, Devanathan AS, Kuruc JD, McGee KS, Schmitz JL, Sebastian J, Shaheen NJ, Ferrari G, McKellar M, Fiscus SA, Hicks CB, Robertson K, Kashuba ADM, Eron JJ, Margolis DM. Efficacy, pharmacokinetics and neurocognitive performance of dual, NRTI-sparing antiretroviral therapy in acute HIV-infection. AIDS. 2020 Nov 1;34(13):1923-1931. doi: 10.1097/QAD.0000000000002652.
PubMed 32773474
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00855413
- Acronym / sponsor ID
- CID 0821
- Conditions
- Acute HIV Infection, HIV Infections
- Keywords
- Acute HIV, HIV, Treatment Naive, Acute Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted by sponsor due to slow enrollment.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Study start
- Mar 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 Mar 2009 (estimated)
- Results
- Posted 17 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Darunavir/Ritonavir and Etravirine | Other | Drug: Darunavir, Drug: Ritonavir, Drug: EtravirineDarunavir/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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (19 listed)
- Women who are pregnant or breast-feeding.
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- Women of reproductive potential who are unwilling or unable to use acceptable methods to avoid pregnancy for the entire study period
- Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry.
- Known allergy/sensitivity to study drugs or their formulations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DarunavirAlso: Prezista800 mg orally once daily | Drug | Darunavir/Ritonavir and Etravirine |
| RitonavirAlso: Norvir100 mg orally once daily | Drug | Darunavir/Ritonavir and Etravirine |
| EtravirineAlso: Intelence200 mg orally twice daily, although patients may choose to take ETR 400 mg QD to have a simpler all QD regimen | Drug | Darunavir/Ritonavir and Etravirine |
Primary outcome
Number of Participants With Virologic Response
Time frame: 24 weeks
Virologic response defined as plasma HIV RNA measurement <200 copies/mL at week 24
37 secondary outcomes
Number of Participants With Virologic Response
Time frame: 48 weeks from enrollment
Median Change in CD4 Cell Count From Week 0 to Week 24.
Time frame: week 0, week 24
Median Change in CD4 Cell Count From Week 0 to Week 48.
Time frame: 48 weeks from enrollment
HIV RNA Levels Immediately Prior to Initiating Study Treatment.
Time frame: HIV RNA level at enrollment
Median Time to HIV RNA Suppression to <200 Copies/mL
Time frame: From enrollment to the date of HIV RNA suppression, assessed up to Week 48
HIV RNA Detection in Semen
Time frame: From enrollment through 48 weeks
Number of Participants Who Stopped Study Treatment Due to Adverse Event or Intolerance
Time frame: Enrollment to Week 48
Adverse Events Possibly or Definitely Related to Study Treatment Through Week 48
Time frame: Enrollment to week 48
Maximum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Time frame: Week 4 and week 48
Minimum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Time frame: Week 4 and week 48
Maximum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Time frame: Week 4 and week 48
Minimum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Time frame: Week 4 and week 48
Maximum Ritonavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Time frame: Week 4 and Week 48
Minimum Ritonavir Exposure Range in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Time frame: Week 4 and week 48
Maximum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen
Time frame: Weeks 0-4 and weeks 12, 48
Minimum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen
Time frame: Weeks 0-4 and weeks 12, 48
Maximum Darunavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen
Time frame: Weeks 0-4 and weeks 12, 48
Minimum Darunavir Exposure Range in Semen Among Participants Who Consented to an Optional Collection of Semen
Time frame: Weeks 0-4 and weeks 12, 48
Maximum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen
Time frame: Weeks 0-4 and Weeks 12, 48
Minimum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen
Time frame: Weeks 0-4 and Weeks 12, 48
Maximum Etravirine Exposure in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Time frame: between Week 4-12 and between Weeks 36-48
Minimum Etravirine Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Time frame: between Week 4-12 and between Weeks 36-48
Maximum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Time frame: between Week 4-12 and between Weeks 36-48
Minimum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Time frame: between week 4-12 and between weeks 36-48
Maximum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Time frame: between week 4-12 and between Weeks 36-48
Minimum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Time frame: between week 4-12 and between weeks 36-48
Number of Participants With HIV RNA Measurement Above the Limits of Detection in Cerebrospinal Fluid
Time frame: Week 4 and Week 48
Number of Participants With Neurocognitive Impairment at Baseline
Time frame: Week 2 or 4
Number of Participants With Neurocognitive Impairment at Week 24
Time frame: Week 24
Number of Participants With Neurocognitive Impairment at Week 48
Time frame: Week 48
Overall Neurocognitive Impairment Score at Week 2 or 4
Time frame: Week 2 or 4
Overall Neurocognitive Impairment at Week 24
Time frame: Week 24
Overall Neurocognitive Impairment at Week 48
Time frame: Week 48
Change in Overall Neurocognitive Impairment From Baseline to Week 24 or 48
Time frame: Baseline to Week 24 or 48
Correlation of HIV RNA Levels in CSF and Drug Levels With Neurocognitive Functioning
Time frame: From enrollment through Week 48
Correlation of Time to HIV RNA Levels <200 Copies/mL With Improvement in Neurocognitive Functioning From Baseline to Week 24 and 48
Time frame: Baseline to Week 24 and 48
HIV RNA Detection in Ileal Biopsy Specimens
Time frame: Weeks 4 and 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21487250Gay CL, Mayo AJ, Mfalila CK, Chu H, Barry AC, Kuruc JD, McGee KS, Kerkau M, Sebastian J, Fiscus SA, Margolis DM, Hicks CB, Ferrari G, Eron JJ; Duke-UNC Acute HIV Infection Consortium. Efficacy of NNRTI-based antiretroviral therapy initiated during acute HIV infection. AIDS. 2011 Apr 24;25(7):941-9. doi: 10.1097/QAD.0b013e3283463c07.
- BackgroundC Gay, O Dibben, A Stacey, N Gasper-Smith, M Liu, N Goonetilleke, G Ferrari, J Eron, C Hicks, A McMichael, B Haynes, P Borrow, M Cohen, the Duke-UNC CHAVI 001 Clinical Working Group. "Effect(s) of antiretroviral treatment on acute HIV infection." XVII International AIDS Conference, 2008 Abstract no. THPE0086.
- Derived from this study: PubMed 32773474Gay CL, Neo DT, Devanathan AS, Kuruc JD, McGee KS, Schmitz JL, Sebastian J, Shaheen NJ, Ferrari G, McKellar M, Fiscus SA, Hicks CB, Robertson K, Kashuba ADM, Eron JJ, Margolis DM. Efficacy, pharmacokinetics and neurocognitive performance of dual, NRTI-sparing antiretroviral therapy in acute HIV-infection. AIDS. 2020 Nov 1;34(13):1923-1931. doi: 10.1097/QAD.0000000000002652.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Gay, MD, MPH principal investigator
University of North Carolina, Chapel Hill
David M Margolis, MD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Darunavir, Ritonavir and Etravirine in people with Acute HIV Infection and HIV Infections, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Virologic Response (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00855413, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.