Acute HIV InfectionPhase 4NCT00924898
Treatment of Acute HIV With Emtricitabine, Tenofovir and Efavirenz (CID 0805)
A Phase 4 study testing efavirenz, emtricitabine, and tenofovir 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
This is a pilot study of treatment of acute HIV infection with a once daily regimen of Emtricitabine, Tenofovir and Efavirenz. The primary objectives of this study are: 1. To determine the safety and tolerability, and the virologic and immunologic efficacy of FTC, TDF, and efavirenz given once daily to patients 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?
- efavirenz, emtricitabine, and tenofovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2005to Dec 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
- Diagnosis of acute HIV infection as defined by protocol.
- The following laboratory parameters verified within 30 days of study entry:
- Bilirubin </= 3.0mg/dL
- ALT/AST </= 10 X upper limit of normal
- Absolute neutrophil count (ANC) >/= 500cells/mm3
- Platelet count >/= 25,000 cells/mm3
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- Hemoglobin >/= 8.5g/dL for men and >/= 8.0 g/dL for women
- Calculated creatinine clearance (Cockcroft-Gault formula) >/= 50mL/min:
- CrCl = (140-age) x body weight (kg) (x 0.85 if female)/ Serum creatinine [mg/dL] x (72)
- All women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of bHCG) within 72 hours prior to start of study medication. WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), who is not postmenopausal (defined as amenorrhea >/=12 consecutive months), or is on hormone replacement therapy (HRT) with documented plasma follicle-stimulating hormone level >/=35mLU/mL. Women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential;
- Be willing to use two effective forms of contraception throughout study. Barrier contraception should always be used in combination with other methods of contraception (oral or other hormonal contraceptives);
- Weigh >/= 40 kg;
Who cannot join
- A life expectancy less than twelve months.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- WOCBP who are unwilling or unable to use two acceptable methods to avoid pregnancy for the entire study period
- WOCBP using a prohibited contraceptive method
- Hypersensitivity to any component of the formulation of study drugs.
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- A clinically important illness not explicitly excluded by the protocol, a physical or psychiatric disability, or a laboratory abnormality that might place the patient at increased risk by being exposed to the medications in this study or which might confound the interpretation of this investigation.
- Proven or suspected acute hepatitis within 30 days prior to study entry (this excludes liver inflammation related to acute HIV infection).
- Intractable diarrhea (>/=6 loose stools/day for at least 7 consecutive days) within 30 days prior to study entry or vomiting lasting more than 4 days within one month prior to dosing (this excludes symptoms attributed to acute HIV infection).
- An active AIDS-defining opportunistic infection or disease (for the purpose of this study, a CD4 count </=200 cells/mm3 in the absence of any other AIDS-defining indicator condition is not considered an AIDS-defining event. AIDS-defining events occurring during the acute HIV infection syndrome period such as Candida esophagitis will be considered on a case-by-case basis and will not be automatically considered exclusionary).
- Inability to communicate effectively with study personnel.
- Current alcohol or recreational drug use which in the investigator's opinion interferes with the subject's ability to comply with dosing schedule and protocol evaluations or increases the risk of developing pancreatitis.
- Incarceration; prisoner recruitment and participation are not permitted.
- Difficulty swallowing capsules/tablets.
- Prior treatment with any other experimental drug for any indication (within 30 days of initiating study treatment).
- Treatment with immune-modulating agents (within 30 days of initiating study treatment) such as cyclosporine and systemic corticosteroids. Routine vaccinations are allowed.
- Therapy with agents with significant systemic neurotoxic pancreotropic or cytotoxic potential within 3 months of study start, or the need for such therapy is expected at the time of enrollment.
- Therapy with nephrotoxic agents (aminoglycosides, IV amphotericin, cidofovir, IV pentamidine, cisplatin other agents with nephrotoxic potential), adefovir or probenecid. These agents must be discontinued at least 30 days prior to starting study medications. Brief course of aminoglycosides within 30 days of enrollment may be allowed after discussion with Study Chairs.
- Concomitant Medications:
- The following medications are expressly prohibited during the course of the trial: Astemizole, cisapride, ergot derivatives, hydroxyurea, midazolam, thalidomide, triazolam, vincristine, zalcitabine, ribavirin, doxorubicin, Voriconazole, St. John's wort or any medications that are contraindicated for concomitant use as described in the current product information packet insert for the ARV therapies used.
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 0805 - Treatment of Acute HIV Infection With a Once Daily Regimen of Emtricitabine, Tenofovir and Efavirenz - A Pilot Study of Response to Therapy and HIV Pathogenesis
This is a pilot study of treatment of acute HIV infection with a once daily regimen of Emtricitabine, Tenofovir and Efavirenz. The primary objectives of this study are:
- To determine the safety and tolerability, and the virologic and immunologic efficacy of FTC, TDF, and efavirenz given once daily to patients with acute HIV infection.
- To assess the impact of once daily therapy combined with a standardized adherence program on treatment adherence, virologic suppression, and rate of viral load decline in blood and infectious fluids (semen, cervico-vaginal secretions).
- To define the prevalence of genotypic and phenotypic resistance to antiretroviral agents among persons diagnosed with acute HIV infection in the Southeastern United States.
Read the detailed description
Hypothesis: Once daily ART with fixed dose combination FTC/TDF/EFV will reduce viral replication to <200 copies RNA/ml plasma in blood and other body compartments in patients with acute HIV infection, reducing infectivity. The treatment regimen will be well tolerated during treatment follow-up. A coordinated program of counseling and support will facilitate adherence and promote successful therapy. Prevalence of transmitted drug resistant HIV-1 will be assessed.
Study Design: Dual-center, prospective, single-arm pilot study of FTC/TDF/EFV in patients with acute HIV infection. Study sites will be members of the Duke-UNC Acute HIV Infection Study Consortium. Patients will be followed intensively for 96 weeks.
- Conditions
- Acute HIV Infection, HIV Infections
- Being tested
- efavirenz, emtricitabine, and tenofovir
- Keywords
- Acute HIV, HIV, Acute Infections, Acute Infection
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efavirenz, emtricitabine, and tenofovirDrug
Also called Tenofovir disoproxil fumarate, Emtricitabine, FDC Emtricitabine 200 mg/ tenofovir 300 mg, Efavirenz
Once daily ART with emtricitabine, tenofovir DF and efavirenz
| Study group | Role | What they receive |
|---|---|---|
| Acute HIV Treatment Group | Experimental | Single arm, open label study in which all participants received the same study treatment with efavirenz, emtricitabine, and tenofovir DF Receives: Drug: efavirenz, emtricitabine, and tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Without Virologic Failure at Week 24
Number of participants with a HIV RNA level <200 copies/mL at week 24
Measured: HIV RNA level prior to or at week 24 following enrollment
Secondary outcomes (5)
Number of Participants Without Virologic Failure at Week 48
HIV RNA level <50 copies/mL at week 48
Measured: HIV RNA level at week 48 following enrollment
Number of Participants With HIV RNA Suppression at Week 96
Number of participants wtih HIV RNA level <50 copies/mL at week 96
Measured: HIV RNA level at 96 weeks following enrollment
Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications
Prevalence of any of the surveillance drug resistance mutations associated with resistance to antiretroviral medications listed by the World Health Organization
Measured: At enrollment
Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment
Baseline genotypic resistance defined as presence of any surveillance drug resistance mutation to any drug in the study treatment listed by the World Health Organization
Measured: At enrollment
Time to HIV RNA Suppression <50 Copies/mL
Number of days from ART initiation to HIV RNA suppression <50 copies/mL
Measured: Number of days from start of study treatment until HIV RNA suppression, assessed through week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startJan 2005
- Primary completionNov 2013
- Study completionDec 2013
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 (2)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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Gilead Sciences
- 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 Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924898
- Sponsor's protocol ID
- CID 0805 (PHI 02)
- Status last verified
- Apr 2017
- First submitted
- 17 Jun 2009
- Last updated
- 16 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gay CL, Willis SJ, Cope AB, Kuruc JD, McGee KS, Sebastian J, Crooks AM, McKellar MS, Margolis DM, Fiscus SA, Hicks CB, Ferrari G, Eron JJ; Duke-UNC Acute HIV Infection Consortium. Fixed-dose combination emtricitabine/tenofovir/efavirenz initiated during acute HIV infection; 96-week efficacy and durability. AIDS. 2016 Nov 28;30(18):2815-2822. doi: 10.1097/QAD.0000000000001255.
PubMed 27662549Gay 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 21487250
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CID 0805 - Treatment of Acute HIV Infection With a Once Daily Regimen of Emtricitabine, Tenofovir and Efavirenz - A Pilot Study of Response to Therapy and HIV Pathogenesis
- ClinicalTrials.gov ID
- NCT00924898
- Acronym / sponsor ID
- CID 0805 (PHI 02)
- Conditions
- Acute HIV Infection, HIV Infections
- Keywords
- Acute HIV, HIV, Acute Infections, Acute Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Gilead Sciences
- Study start
- Jan 2005
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Jun 2009 (estimated)
- Results
- Posted 16 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study of treatment of acute HIV infection with a once daily regimen of Emtricitabine, Tenofovir and Efavirenz. The primary objectives of this study are:
- To determine the safety and tolerability, and the virologic and immunologic efficacy of FTC, TDF, and efavirenz given once daily to patients with acute HIV infection.
- To assess the impact of once daily therapy combined with a standardized adherence program on treatment adherence, virologic suppression, and rate of viral load decline in blood and infectious fluids (semen, cervico-vaginal secretions).
- To define the prevalence of genotypic and phenotypic resistance to antiretroviral agents among persons diagnosed with acute HIV infection in the Southeastern United States.
Detailed description
Hypothesis: Once daily ART with fixed dose combination FTC/TDF/EFV will reduce viral replication to <200 copies RNA/ml plasma in blood and other body compartments in patients with acute HIV infection, reducing infectivity. The treatment regimen will be well tolerated during treatment follow-up. A coordinated program of counseling and support will facilitate adherence and promote successful therapy. Prevalence of transmitted drug resistant HIV-1 will be assessed.
Study Design: Dual-center, prospective, single-arm pilot study of FTC/TDF/EFV in patients with acute HIV infection. Study sites will be members of the Duke-UNC Acute HIV Infection Study Consortium. Patients will be followed intensively for 96 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute HIV Treatment Group | Experimental | Drug: efavirenz, emtricitabine, and tenofovirSingle arm, open label study in which all participants received the same study treatment with efavirenz, emtricitabine, and tenofovir DF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of acute HIV infection as defined by protocol.
- The following laboratory parameters verified within 30 days of study entry:
- CrCl = (140-age) x body weight (kg) (x 0.85 if female)/ Serum creatinine [mg/dL] x (72)
- All women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of bHCG) within 72 hours prior to start of study medication. WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), who is not postmenopausal (defined as amenorrhea >/=12 consecutive months), or is on hormone replacement therapy (HRT) with documented plasma follicle-stimulating hormone level >/=35mLU/mL. Women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential;
- Be willing to use two effective forms of contraception throughout study. Barrier contraception should always be used in combination with other methods of contraception (oral or other hormonal contraceptives);
Key exclusion criteria (20 listed)
- A life expectancy less than twelve months.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- WOCBP who are unwilling or unable to use two acceptable methods to avoid pregnancy for the entire study period
- WOCBP using a prohibited contraceptive method
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 |
|---|---|---|
| efavirenz, emtricitabine, and tenofovirAlso: Tenofovir disoproxil fumarate, Emtricitabine, FDC Emtricitabine 200 mg/ tenofovir 300 mg, EfavirenzOnce daily ART with emtricitabine, tenofovir DF and efavirenz | Drug | Acute HIV Treatment Group |
Primary outcome
Number of Participants Without Virologic Failure at Week 24
Time frame: HIV RNA level prior to or at week 24 following enrollment
Number of participants with a HIV RNA level <200 copies/mL at week 24
5 secondary outcomes
Number of Participants Without Virologic Failure at Week 48
Time frame: HIV RNA level at week 48 following enrollment
Number of Participants With HIV RNA Suppression at Week 96
Time frame: HIV RNA level at 96 weeks following enrollment
Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications
Time frame: At enrollment
Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment
Time frame: At enrollment
Time to HIV RNA Suppression <50 Copies/mL
Time frame: Number of days from start of study treatment until HIV RNA suppression, assessed through week 96
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27662549Gay CL, Willis SJ, Cope AB, Kuruc JD, McGee KS, Sebastian J, Crooks AM, McKellar MS, Margolis DM, Fiscus SA, Hicks CB, Ferrari G, Eron JJ; Duke-UNC Acute HIV Infection Consortium. Fixed-dose combination emtricitabine/tenofovir/efavirenz initiated during acute HIV infection; 96-week efficacy and durability. AIDS. 2016 Nov 28;30(18):2815-2822. doi: 10.1097/QAD.0000000000001255.
- Results publication: 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.
- Individual participant dataSharing planned: No
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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
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 efavirenz, emtricitabine, and tenofovir 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 12 inclusion and 20 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: finished, as of the sponsor's last update on 16 May 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 16 May 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 Without Virologic Failure at Week 24 (time frame: HIV RNA level prior to or at week 24 following enrollment). 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 NCT00924898, which also lists 2 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 16 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.