HIV InfectionsPhase 2NCT00350272
Elvucitabine/Efavirenz/Tenofovir Versus Lamivudine/Efavirenz/Tenofovir in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-naive Participants
A Phase 2 study testing Elvucitabine, Lamivudine and Tenofovir in people with HIV Infections, run by Alexion Pharmaceuticals, Inc. at 26 sites in 2 countries.
Trial summary
Elvucitabine, a novel nucleoside analog, is being studied as a treatment for participants with human immunodeficiency virus (HIV)-1. This Phase 2 study will enroll 60 HIV-1-naive participants to assess the efficacy and safety of elvucitabine compared to lamivudine in combination with tenofovir and efavirenz as… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Elvucitabine, Lamivudine and Tenofovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 26 sitesin 2 countries
- Study dates
- May 2006to Apr 2009
- Phase
- Phase 2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A participant must meet the following criteria at Screening to be enrolled in this study:
- Are male or female. Sexually active men with partners of childbearing potential must agree to use an acceptable form of contraception as determined by the investigator (for example, oral contraceptives, double-barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or vasectomy) during participation in the study. Female participants cannot be pregnant or lactating/breast-feeding and must be surgically sterile, postmenopausal as defined later, or practicing an effective method of birth control as determined by the investigator (for example oral contraceptives, double-barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy). A woman may be considered postmenopausal if she is at least 50 years or older, has a history of no menses for at least 12 months, and has a follicle-stimulating hormone (FSH) level over the upper limit of normal for reproductive aged women.
- Are 18 through 65 years old
- Have documented HIV-1 infection by written prior history and clinically stable with no AIDS-defining events in the 3 months prior to Screening
- Have plasma HIV-1 RNA levels greater than or equal to 5000 copies/mL at Screening
- Are HIV-1 strain sensitive to elvucitabine, lamivudine, or emtricitabine as demonstrated by the absence of the M184V, M184I, and D237E mutations by TRUGENE HIV-1 Genotyping Kit
Show all 17Show fewer
- Are HIV-1 strain genotypically sensitive to efavirenz (negative for K103 and Y188L mutations) and tenofovir (negative for K65R mutation) by TRUGENE HIV-1 Genotyping Kit
- Have a CD4 count greater than or equal to 200 cells/mL and less than 500 cells/mL
- Have acceptable hematologic and chemistry parameters, including the following:
- Hemoglobin (Hgb) greater than or equal to 11 grams (g)/deciliter (dL)
- Absolute neutrophil count greater than or equal to 2000 cells/mm^3
- Platelets greater than or equal to 125 000/mm^3
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 1.5 times the upper limit of normal
- Total bilirubin less than or equal to 1.5 times the upper limit of normal
- Creatinine within normal range
- Are capable of understanding and has signed the informed consent document
- Are able and willing to comply with protocol requirements
Who cannot join
- Participants meeting any of the following criteria at Screening will be excluded from the study:
- Are hepatitis B surface antigen positive, and/or hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive
- Have previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within the 3 months prior to Screening or the expected need for such therapy during the study
- Have previous use or need for bone marrow colony-stimulating factors such as Epogen, Procrit, or Neupogen
- Have had previous antiretroviral therapy
- Have evidence or history of cirrhosis
Show all 12Show fewer
- Have recent (within 3 months of Screening) history of alcohol abuse, physical dependence to any opioid, cocaine, lysergic acid diethylamide (LSD) or amphetamines, or history of drug addiction within the last 12 months
- Have inability to tolerate oral medication
- Are pregnant or breast-feeding if female
- Have any clinical condition or prior therapy that, in the investigator's opinion, would make the participant unsuitable for the study or unable to comply with the dosing requirements
- Have received treatment with any other investigational drug within 30 days prior to Screening
- Have current active mental illness or a history of significant mental illness (for example, severe depression, schizophrenia, history of suicidal ideations, or suicide attempts)
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States25 sites
Clinical Trial Site
Austin, Texas, 75705
Clinical Trial Site
Boston, Massachusetts, 02215
Clinical Trial Site
Chicago, Illinois, 60611
Clinical Trial Site
Clearwater, Florida, 33765
Clinical Trial Site
Dallas, Texas, 75204
Clinical Trial Site
Fort Myers, Florida, 33901
Clinical Trial Site
Hampton, Virginia, 23666
Clinical Trial Site
Houston, Texas, 77004
Clinical Trial Site
Houston, Texas, 77009
Clinical Trial Site
Houston, Texas, 77030
Clinical Trial Site
Houston, Texas, 77098
Clinical Trial Site
Little Rock, Arkansas, 72207
Clinical Trial Site
Long Beach, California, 90813
Clinical Trial Site
Los Angeles, California, 90069
Clinical Trial Site
Miami, Florida, 33133
Clinical Trial Site
Miami, Florida, 33136
Clinical Trial Site
New York, New York, 10003
Clinical Trial Site
Newark, New Jersey, 07102
Clinical Trial Site
Orlando, Florida, 32803
Clinical Trial Site
Tampa, Florida, 33602
Clinical Trial Site
Tampa, Florida, 33614
Clinical Trial Site
Washington D.C, Maryland, 20007
Clinical Trial Site
Washington D.C., District of Columbia, 20007
Clinical Trial Site
West Palm Beach, Florida, 33401
Clinical Trial Site
Wichita, Kansas, 67214
About this study
Official title: A Randomized, Blinded, 12-week Comparison of Elvucitabine/Efavirenz/Tenofovir Versus Lamivudine/Efavirenz/Tenofovir in HIV-1 Infected Treatment-naive Participants. There is a 36 Week, Open-label, Extension Phase for Eligible Participants.
Elvucitabine, a novel nucleoside analog, is being studied as a treatment for participants with human immunodeficiency virus (HIV)-1. This Phase 2 study will enroll 60 HIV-1-naive participants to assess the efficacy and safety of elvucitabine compared to lamivudine in combination with tenofovir and efavirenz as measured by changes in the participant's HIV-ribonucleic acid (RNA) level and CD4 cell count. The study treatment will be 12 weeks of blinded study medication followed by an additional 84 weeks of open-label treatment if the participant's response to treatment meets certain endpoints. The pharmacokinetics of elvucitabine will also be assessed during the study.
Read the detailed description
Sixty HIV-1-infected, clinically stable, treatment-naïve adults with no acquired immunodeficiency syndrome (AIDS)-defining events during the 3 months prior to screening will be randomly assigned to 1 of 2 treatment groups. Participant plasma HIV-1 RNA levels must be greater than or equal to 5000 copies/millimeter (mL), and CD4 cell counts must be greater than 200 cells/mL and less than 500 cells/mL at Screening. Participants must be sensitive to elvucitabine, lamivudine, and emtricitabine as demonstrated by the absence of the M184V, M184I, and D237E mutations by TRUGENE HIV-1 Genotyping Kit. Participants must be genotypically sensitive to efavirenz (negative for K103 or Y188L mutations) and tenofovir (negative for K65R mutation) as demonstrated by TRUGENE HIV-1 Genotyping Kit. They must have acceptable hematologic and chemistry parameters.
Participants whose HIV-1 RNA levels have decreased at least 2 logs or to below 400 copies/mL by Week 10 may be considered eligible to enter the extension phase of up to 36 weeks of additional treatment. Participants in the extension phase will be evaluated at Weeks 14 and 16 and every 4 Weeks until Week 96.
Once all participants have completed 12 weeks of treatment, and the data are available for all visits through Week 12, the database will be locked and the treatment assignments will be unblinded. Any participant who has had less than 48 weeks of treatment will be allowed to continue on the same treatment as initially assigned on an open-label basis through 48 weeks. All participants will have 2 post-treatment follow-up visits, at 1 and 4 weeks after the end of treatment. Concentrations of elvucitabine in the plasma will be measured on Day 1, at Weeks 4, 6, 8, 12, 16, 24, 48, 72, 96, and at Follow-up
Efficacy will be assessed by measuring plasma HIV-1 RNA levels and CD4 counts at each study visit.
Safety evaluation will include vital signs, physical examinations, electrocardiograms, assessments of adverse events (AEs), measurement of plasma HIV-1 RNA levels and CD4 counts, determination of HIV-1 genotype at Screening and at Weeks 12, 24, 48, and 96, determination of HIV-1 phenotype at Visit 1 and at Weeks 12, 24, 48, and 96 urine and serum pregnancy tests, as well as laboratory analyses that include hematology, chemistry, and urinalysis.
- Conditions
- HIV Infections
- Being tested
- Elvucitabine, Lamivudine, Tenofovir, Efavirenz
- Keywords
- HIV-1 treatment naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElvucitabineDrug
Also called ACH-126,443
Elvucitabine 10 mg orally daily
LamivudineDrug
Also called 3TC
Lamivudine 300 mg orally daily
TenofovirDrug
Also called Viread
Tenofovir open-label 300 mg orally daily
EfavirenzDrug
Also called Sustiva
Efavirenze open-label 600 mg orally daily
| Study group | Role | What they receive |
|---|---|---|
| Elvucitabine, Efavirenz, Tenofovir | Experimental | Elvucitabine (blinded) 10 milligrams (mg)/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible participants continued with an additional 84 weeks of open-label treatment (through Week 96).
Participants who experienced at least a 2 log10 decrease in HIV-1 RNA from Baseline or who had an HIV-1 RNA level of less than 400 copies/ mL at Week 10 and had not experienced any Grade 3 or 4 hematological toxicity as of the Week 10 measurement were considered eligible for an additional 84 weeks of open-label treatment after Week 12. Receives: Drug: Elvucitabine; Drug: Tenofovir; Drug: Efavirenz |
| Lamivudine, Efavirenz, Tenofovir | Active comparator | Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible participants continued with an additional 84 weeks of open-label treatment (through Week 96).
Participants who experienced at least a 2 log10 decrease in HIV-1 RNA from Baseline or who had an HIV-1 RNA level of less than 400 copies/mL at Week 10 and had not experienced any Grade 3 or 4 hematological toxicity as of the Week 10 measurement were considered eligible for an additional 84 weeks of open-label treatment after Week 12. Receives: Drug: Lamivudine; Drug: Tenofovir; Drug: Efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion Of Participants With Virologic Response For 10 mg/Day Elvucitabine In HIV-1-Infected Participants By 12 Weeks Compared With The Proportion Of Participants With Lamivudine 300 mg/Day
The proportion of participants having achieved a virologic response for elvucitabine 10 mg/day in combination with efavirenz and tenofovir in HIV-1-infected participants over 12 weeks compared with the proportion of participants having achieved a virologic response for lamivudine 300 mg/day in combination with efavirenz and tenofovir. Virologic response was defined as having achieved undetectable (<50 copies/mL) HIV-1 RNA levels from baseline assessment.
Measured: 12 weeks
The Safety Profile Of Elvucitabine.
Determination of the safety profile of elvucitabine as defined by the frequency, type and severity of treatment-emergent adverse events (AEs) and the frequency of Grade 3 and Grade 4 laboratory abnormalities.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startMay 2006
- Primary completionAug 2007
- Study completionApr 2009
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.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Achillion, a wholly owned subsidiary of Alexion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350272
- Sponsor's protocol ID
- ACH443-015
- Status last verified
- Aug 2023
- First submitted
- 6 Jul 2006
- Last updated
- 30 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Individual participant data are available to only this study's Principal Investigator upon request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, 12-week Comparison of Elvucitabine/Efavirenz/Tenofovir Versus Lamivudine/Efavirenz/Tenofovir in HIV-1 Infected Treatment-naive Participants. There is a 36 Week, Open-label, Extension Phase for Eligible Participants.
- ClinicalTrials.gov ID
- NCT00350272
- Acronym / sponsor ID
- ACH443-015
- Conditions
- HIV Infections
- Keywords
- HIV-1 treatment naive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Achillion, a wholly owned subsidiary of Alexion
- Study start
- May 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 10 Jul 2006 (estimated)
- Results
- Posted 22 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Elvucitabine, a novel nucleoside analog, is being studied as a treatment for participants with human immunodeficiency virus (HIV)-1. This Phase 2 study will enroll 60 HIV-1-naive participants to assess the efficacy and safety of elvucitabine compared to lamivudine in combination with tenofovir and efavirenz as measured by changes in the participant's HIV-ribonucleic acid (RNA) level and CD4 cell count. The study treatment will be 12 weeks of blinded study medication followed by an additional 84 weeks of open-label treatment if the participant's response to treatment meets certain endpoints. The pharmacokinetics of elvucitabine will also be assessed during the study.
Detailed description
Sixty HIV-1-infected, clinically stable, treatment-naïve adults with no acquired immunodeficiency syndrome (AIDS)-defining events during the 3 months prior to screening will be randomly assigned to 1 of 2 treatment groups. Participant plasma HIV-1 RNA levels must be greater than or equal to 5000 copies/millimeter (mL), and CD4 cell counts must be greater than 200 cells/mL and less than 500 cells/mL at Screening. Participants must be sensitive to elvucitabine, lamivudine, and emtricitabine as demonstrated by the absence of the M184V, M184I, and D237E mutations by TRUGENE HIV-1 Genotyping Kit. Participants must be genotypically sensitive to efavirenz (negative for K103 or Y188L mutations) and tenofovir (negative for K65R mutation) as demonstrated by TRUGENE HIV-1 Genotyping Kit. They must have acceptable hematologic and chemistry parameters.
Participants whose HIV-1 RNA levels have decreased at least 2 logs or to below 400 copies/mL by Week 10 may be considered eligible to enter the extension phase of up to 36 weeks of additional treatment. Participants in the extension phase will be evaluated at Weeks 14 and 16 and every 4 Weeks until Week 96.
Once all participants have completed 12 weeks of treatment, and the data are available for all visits through Week 12, the database will be locked and the treatment assignments will be unblinded. Any participant who has had less than 48 weeks of treatment will be allowed to continue on the same treatment as initially assigned on an open-label basis through 48 weeks. All participants will have 2 post-treatment follow-up visits, at 1 and 4 weeks after the end of treatment. Concentrations of elvucitabine in the plasma will be measured on Day 1, at Weeks 4, 6, 8, 12, 16, 24, 48, 72, 96, and at Follow-up
Efficacy will be assessed by measuring plasma HIV-1 RNA levels and CD4 counts at each study visit.
Safety evaluation will include vital signs, physical examinations, electrocardiograms, assessments of adverse events (AEs), measurement of plasma HIV-1 RNA levels and CD4 counts, determination of HIV-1 genotype at Screening and at Weeks 12, 24, 48, and 96, determination of HIV-1 phenotype at Visit 1 and at Weeks 12, 24, 48, and 96 urine and serum pregnancy tests, as well as laboratory analyses that include hematology, chemistry, and urinalysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elvucitabine, Efavirenz, Tenofovir | Experimental | Drug: Elvucitabine, Drug: Tenofovir, Drug: EfavirenzElvucitabine (blinded) 10 milligrams (mg)/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible participants continued with an additional 84 weeks of open-label treatment (through Week 96). Participants who experienced at least a 2 log10 decrease in HIV-1 RNA from Baseline or who had an HIV-1 RNA level of less than 400 copies/ mL at Week 10 and had not experienced any Grade 3 or 4 hematological toxicity as of the Week 10 measurement were considered eligible for an additional 84 weeks of open-label treatment after Week 12. |
| Lamivudine, Efavirenz, Tenofovir | Active comparator | Drug: Lamivudine, Drug: Tenofovir, Drug: EfavirenzLamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible participants continued with an additional 84 weeks of open-label treatment (through Week 96). Participants who experienced at least a 2 log10 decrease in HIV-1 RNA from Baseline or who had an HIV-1 RNA level of less than 400 copies/mL at Week 10 and had not experienced any Grade 3 or 4 hematological toxicity as of the Week 10 measurement were considered eligible for an additional 84 weeks of open-label treatment after Week 12. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Are male or female. Sexually active men with partners of childbearing potential must agree to use an acceptable form of contraception as determined by the investigator (for example, oral contraceptives, double-barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or vasectomy) during participation in the study. Female participants cannot be pregnant or lactating/breast-feeding and must be surgically sterile, postmenopausal as defined later, or practicing an effective method of birth control as determined by the investigator (for example oral contraceptives, double-barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy). A woman may be considered postmenopausal if she is at least 50 years or older, has a history of no menses for at least 12 months, and has a follicle-stimulating hormone (FSH) level over the upper limit of normal for reproductive aged women.
- Are 18 through 65 years old
- Have documented HIV-1 infection by written prior history and clinically stable with no AIDS-defining events in the 3 months prior to Screening
- Have plasma HIV-1 RNA levels greater than or equal to 5000 copies/mL at Screening
- Are HIV-1 strain sensitive to elvucitabine, lamivudine, or emtricitabine as demonstrated by the absence of the M184V, M184I, and D237E mutations by TRUGENE HIV-1 Genotyping Kit
Key exclusion criteria (12 listed)
- Participants meeting any of the following criteria at Screening will be excluded from the study:
- Are hepatitis B surface antigen positive, and/or hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive
- Have previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within the 3 months prior to Screening or the expected need for such therapy during the study
- Have previous use or need for bone marrow colony-stimulating factors such as Epogen, Procrit, or Neupogen
- Have had previous antiretroviral therapy
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 |
|---|---|---|
| ElvucitabineAlso: ACH-126,443Elvucitabine 10 mg orally daily | Drug | Elvucitabine, Efavirenz, Tenofovir |
| LamivudineAlso: 3TCLamivudine 300 mg orally daily | Drug | Lamivudine, Efavirenz, Tenofovir |
| TenofovirAlso: VireadTenofovir open-label 300 mg orally daily | Drug | Elvucitabine, Efavirenz, Tenofovir, Lamivudine, Efavirenz, Tenofovir |
| EfavirenzAlso: SustivaEfavirenze open-label 600 mg orally daily | Drug | Elvucitabine, Efavirenz, Tenofovir, Lamivudine, Efavirenz, Tenofovir |
Primary outcome
The Proportion Of Participants With Virologic Response For 10 mg/Day Elvucitabine In HIV-1-Infected Participants By 12 Weeks Compared With The Proportion Of Participants With Lamivudine 300 mg/Day
Time frame: 12 weeks
The proportion of participants having achieved a virologic response for elvucitabine 10 mg/day in combination with efavirenz and tenofovir in HIV-1-infected participants over 12 weeks compared with the proportion of participants having achieved a virologic response for lamivudine 300 mg/day in combination with efavirenz and tenofovir. Virologic response was defined as having achieved undetectable (<50 copies/mL) HIV-1 RNA levels from baseline assessment.
The Safety Profile Of Elvucitabine.
Time frame: 12 weeks
Determination of the safety profile of elvucitabine as defined by the frequency, type and severity of treatment-emergent adverse events (AEs) and the frequency of Grade 3 and Grade 4 laboratory abnormalities.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data are available to only this study's Principal Investigator upon request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elvucitabine, Lamivudine and Tenofovir in people with HIV Infections, run by Alexion Pharmaceuticals, Inc. at 26 sites in 2 countries.
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 12 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 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 22 Mar 2016). 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?
The Proportion Of Participants With Virologic Response For 10 mg/Day Elvucitabine In HIV-1-Infected Participants By 12 Weeks Compared With The Proportion Of Participants With Lamivudine 300 mg/Day (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2023.