HIV InfectionsPhase 2/3NCT00612898
Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection
A Phase 2/3 study testing apricitabine and lamivudine in people with HIV Infections, run by Avexa at 100 sites in 11 countries.
Trial summary
Apricitabine is a new NRTI which is active against drug-resistant HIV. NRTIs are often included as part of patients' treatment, but many HIV-infected patients develop resistance to commonly used NRTIs such as lamivudine (3TC) and emtricitabine (FTC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- apricitabine and lamivudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 100 sitesin 11 countries
- Study dates
- Feb 2008to Jan 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- HIV-1 positive with M184V/I mutation in reverse transcriptase;
- 18 years of age or older;
- Currently taking lamivudine (3TC) or emtricitabine (FTC)
Who cannot join
- Female patients who are pregnant or breastfeeding;
- Current hepatitis B virus (HBV) infection;
- Current treatment for hepatitis C virus infection;
- Renal function not adequate
Trial locations and contacts
100 sites in 11 countries.
100 sites in 11 countries
United States33 sites
Summa Health System
Akron, Ohio, 44304-1430
Aids Research Consortium Of Atlanta Inc.
Atlanta, Georgia, 30308
Atlanta Infectious Disease Group, PC
Atlanta, Georgia, 30309
Central Texas Clinical Research
Austin, Texas, 78705
UAB, 845 19th St South, South Beville Biomedical Research Building
Birmingham, Alabama, 35294-2170
University of Alabama at Birmingham
Birmingham, Alabama, 35294-2170
Fenway Community Health Center
Boston, Massachusetts, 02115
Community Research Intiative of New England
Boston, Massachusetts, 02215-3319
Northwestern University
Chicago, Illinois, 60611
Nicholaos C Bellos, MD, PA
Dallas, Texas, 75204
North Texas Infectious Diseases Consultants, P.A.
Dallas, Texas, 75246
Denver Health & Hospital Authority
Denver, Colorado, 80204
Gary Richmond, MD
Fort Lauderdale, Florida, 33316
Tarrant County Infection Disease Associates
Fort Worth, Texas, 76104
University of Texas Medical Brach
Galveston, Texas, 77555-0435
I.D. Care, Inc.
Hillsborough, New Jersey, 08844-4254
University of Hawaii
Honolulu, Hawaii, 96816-2333
Therapeutic Concepts
Houston, Texas, 77004
Resarch Access Network
Houston, Texas, 77098
Living Hope Clinical Foundation, Inc
Long Beach, California, 90813
DCOL Center for Clinical Research
Longview, Texas, 75605
Saint Michael's Medical Center
Newark, New Jersey, 07102
Orlando Immunology Center
Orlando, Florida, 32803
Southwest Center for HIV/AIDS
Phoenix, Arizona, 85006
The Research & Education Institute
Portland, Oregon, 97209
Kaiser Permanente Medical Center
San Francisco, California, 94115
Swedish Medical Center
Seattle, Washington, 98104
Infectious Disease Research Institute, Inc
Tampa, Florida, 33614
Treasure Coast Infectious Diseases Consultants
Vero Beach, Florida, 32960
Georgetown University
Washington D.C., District of Columbia, 20007
George Washington University
Washington D.C., District of Columbia, 20037
AIDS Research Alliance
West Hollywood, California, 90069
University of Kansas School of Medicine
Wichita, Kansas, 67214
Germany13 sites
EPIMED GmbH
Berlin, 12157
Charite-Universitatsmedizin Berlin
Berlin, 13353
Ruhr-Universitat Bochum
Bochum, 44791
Universitatsklinikum Bonn
Bonn, 53105
Klinikum Dortmund gGmbH
Dortmund, 44137
Universitatsklinikum Essen
Essen, 45122
Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt, 60590
Praxis fuer Innere Medizin
Freiburg im Breisgau, 79098
Praxis Dr.Schneider
Fürth, 90762
Dr. med. Birger Kuhlmann
Hanover, 30159
Klinikum der Universitat Munchen - Innenstadt
München, 80336
Gemeinschaftspraxis E. Schnaitmann, Dr. med. A. Schaffert, Dr. med. A. Trein, Dr. med. E. Ibler
Stuttgart, 70197
Praxis Dres. Ulmer, Frietsch, Muller
Stuttgart, 70197
Italy10 sites
Ospedale S.Maria Annunziata
Antella, 50011
Azienda Ospedaliera Universitaria di Ferrara Arcispedale S.Anna
Ferrara, 44100
Azienda Ospedaliera Universitaria San Martino
Genova, 16132
Fondazione Centro San Raffaele del Monte Tabor
Milan, 20127
Ospedale Luigi Sacco
Milan, 20157
Azienda Ospedaliero-Universitaria di Modena Policlinico
Modena, 41100
Azienda Ospedaliera Cotugno
Naples, 80131
Azienda Ospedaliera di Padova
Padova, 35128
Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
Roma, 149
Comprensorio Amedeo di Savoia - Birago Di Vische
Torino, 10149
Australia8 sites
Carlton Clinic
Carlton, Victoria, 3053
Melbourne Sexual Health Centre
Carlton, Victoria, 3053
407 Doctors
Darlinghurst, New South Wales, 2010
The Alfred
Melbourne, Victoria
Royal Melbourne Hospital
Parkville, Victoria, 3050
Parramatta Sexual Health Clinic
Parramatta, New South Wales, 2150
Prahran Market Clinic
South Yarra, Victoria, 3141
Westmead Hospital
Westmead, New South Wales, 2145
Thailand8 sites
Mahidol University Hospital for Tropical Diseases
Bangkok, 10270
Pharmongkutklao Hospital
Bangkok, 10330
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, 10330
Ramathibodi Hospital, Mahidol University
Bangkok, 10400
Sirraj Hospital, Mahidol Universoty
Bangkok, 10700
Maharaj Nakorn Chiang Mai, Chiang Mai University
Chiang Mai, 50002
Khon Kaen University
Khon Kaen, 40002
Bamrasnaradura Institution
Nonthaburi, 11000
Israel6 sites
Soroka University Medical Center
Beersheba, 84101
Rambam Medical Center
Haifa, 31096
Hadassah University Hospital Ein Kerem
Jerusalem, 91120
The Chaim Sheba Medical Center
Ramat Gan, 52621
Kaplan Medical Center
Rehovot, 76100
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
Peru6 sites
Hospital Nacional CASE-EsSalud
Arequipa, 0
Investigaciones Medicas en Salud
Lima, 14
Hospital Dos de Mayo
Lima, 1
Via Libre
Lima, 1
Hospital Nacional Cayetano Heredia
Lima, 31
Edgardo Rebagliati Hospital
Lima
Canada5 sites
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8N 3Z5
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, G1V 4G2
University Health Network
Toronto, Ontario, H5G 2C4
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Ubc Downtown I.D. Clinic
Vancouver, British Columbia, V6Z 2C7
United Kingdom5 sites
Birmingham Heartlands Hospital
Birmingham, B9 5SS
St Bartholomew's Hospital
London, EC1A 7BE
Royal Free Hospital
London, NW3 2QG
Guy's King's & St. Thomas' School of Medicine
London, SE5 9RJ
St Mary's Hospital
London, W2 1NY
Belgium3 sites
Prins Leopold Institute voor Tropische Geneeskunde
Antwerp, 2000
Hopitaux IRIS Sud
Brussels, 1000
Cliniques Universitaires Saint-Luc
Brussels, 1200
Puerto Rico3 sites
Instituto De Investigacion Cientifica
Ponce, 731
University of Puerto Rico
San Juan, 00936-5067
Hope Clinical Research
San Juan, 909
About this study
Official title: A Phase 2b/3, Randomized, Double Blind, Dose Confirming Study of the Safety, Efficacy and Tolerability of Apricitabine Versus Lamivudine in Treatment-experienced HIV-1 Infected Patients With the M184V/I Mutation in Reverse Transcriptase
Apricitabine is a new NRTI which is active against drug-resistant HIV. NRTIs are often included as part of patients' treatment, but many HIV-infected patients develop resistance to commonly used NRTIs such as lamivudine (3TC) and emtricitabine (FTC). This study will examine whether including apricitabine as part of patients' treatment is more effective than including lamivudine,when patients change treatment because of drug resistance.
Read the detailed description
ATC has potent antiviral activity both in vitro (against wild-type HIV-1 and HIV-1 with mutations in reverse transcriptase that confer resistance to NRTIs), and in clinical studies in both treatment-naïve and treatment-experienced patients with M184V, including in the presence of additional NRTI mutations in reverse transcriptase.
The M184V mutation is most commonly present amongst patients failing regimens containing either of the two deoxycytidine analogs lamivudine and emtricitabine. Whilst lamivudine therapy is often maintained in patients harboring the M184V mutation in some settings, there are no deoxycytidine analogs currently available that effectively suppress replication of HIV-1 containing the M184V/I mutation, particularly in the presence of other additional NRTI mutations.
The purpose of this study is to extend the efficacy and safety established in study AVX-201 of ATC in patients who are HIV-1 infected and have failed treatment with lamivudine or emtricitabine and have confirmed M184V/I mutation. Patients to be enrolled will be failing their current lamivudine- or emtricitabine-containing regimen and therefore have limited remaining NRTI treatment options. This study will investigate whether it is possible to improve control of HIV-1 viral replication by including ATC within a treatment experienced patient's new optimized background regimen following ART treatment failure.
- Conditions
- HIV Infections
- Being tested
- apricitabine, lamivudine
- Keywords
- HIV infection, Drug resistance, Reverse transcriptase inhibitor, Nucleoside analogue, treatment experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apricitabineDrug
Also called AVX754
800mg BID apricitabine orally for 48 weeks
lamivudineDrug
Also called 3TC
150mg BID lamivudine orally for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 800mg BID apricitabine plus optimised background Receives: Drug: apricitabine |
| 2 | Active comparator | 150mg BID lamivudine plus optimised background Receives: Drug: lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W24
Measured: week 24
Secondary outcomes (2)
Time to loss of virological response (TLOVR analysis; FDA algorithm) at W12, W24 and W48 (<50 copies/mL)
Measured: week 12, 24, and 48
Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W48
Measured: week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avexa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan W Cox, Ph D, Study director, Avexa LtdMichael Saag, MD, Principal investigator, UAB Center for AIDS Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612898
- Sponsor's protocol ID
- AVX-301
- Status last verified
- Jan 2012
- First submitted
- 30 Jan 2008
- Last updated
- 23 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b/3, Randomized, Double Blind, Dose Confirming Study of the Safety, Efficacy and Tolerability of Apricitabine Versus Lamivudine in Treatment-experienced HIV-1 Infected Patients With the M184V/I Mutation in Reverse Transcriptase
- ClinicalTrials.gov ID
- NCT00612898
- Acronym / sponsor ID
- AVX-301
- Conditions
- HIV Infections
- Keywords
- HIV infection, Drug resistance, Reverse transcriptase inhibitor, Nucleoside analogue, treatment experienced
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 239 participants (actual)
- Lead sponsor
- AvexaIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 12 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Apricitabine is a new NRTI which is active against drug-resistant HIV. NRTIs are often included as part of patients' treatment, but many HIV-infected patients develop resistance to commonly used NRTIs such as lamivudine (3TC) and emtricitabine (FTC). This study will examine whether including apricitabine as part of patients' treatment is more effective than including lamivudine,when patients change treatment because of drug resistance.
Detailed description
ATC has potent antiviral activity both in vitro (against wild-type HIV-1 and HIV-1 with mutations in reverse transcriptase that confer resistance to NRTIs), and in clinical studies in both treatment-naïve and treatment-experienced patients with M184V, including in the presence of additional NRTI mutations in reverse transcriptase.
The M184V mutation is most commonly present amongst patients failing regimens containing either of the two deoxycytidine analogs lamivudine and emtricitabine. Whilst lamivudine therapy is often maintained in patients harboring the M184V mutation in some settings, there are no deoxycytidine analogs currently available that effectively suppress replication of HIV-1 containing the M184V/I mutation, particularly in the presence of other additional NRTI mutations.
The purpose of this study is to extend the efficacy and safety established in study AVX-201 of ATC in patients who are HIV-1 infected and have failed treatment with lamivudine or emtricitabine and have confirmed M184V/I mutation. Patients to be enrolled will be failing their current lamivudine- or emtricitabine-containing regimen and therefore have limited remaining NRTI treatment options. This study will investigate whether it is possible to improve control of HIV-1 viral replication by including ATC within a treatment experienced patient's new optimized background regimen following ART treatment failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: apricitabine800mg BID apricitabine plus optimised background |
| 2 | Active comparator | Drug: lamivudine150mg BID lamivudine plus optimised background |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV-1 positive with M184V/I mutation in reverse transcriptase;
- 18 years of age or older;
- Currently taking lamivudine (3TC) or emtricitabine (FTC)
Key exclusion criteria (4 listed)
- Female patients who are pregnant or breastfeeding;
- Current hepatitis B virus (HBV) infection;
- Current treatment for hepatitis C virus infection;
- Renal function not adequate
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 |
|---|---|---|
| apricitabineAlso: AVX754800mg BID apricitabine orally for 48 weeks | Drug | 1 |
| lamivudineAlso: 3TC150mg BID lamivudine orally for 48 weeks | Drug | 2 |
Primary outcome
Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W24
Time frame: week 24
2 secondary outcomes
Time to loss of virological response (TLOVR analysis; FDA algorithm) at W12, W24 and W48 (<50 copies/mL)
Time frame: week 12, 24, and 48
Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W48
Time frame: week 48
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2012.
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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.
Susan W Cox, Ph D study director
Avexa Ltd
Michael Saag, MD principal investigator
UAB Center for AIDS Research
100 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing apricitabine and lamivudine in people with HIV Infections, run by Avexa at 100 sites in 11 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 3 inclusion and 4 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 23 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 100 sites in United States, Germany, Italy, Australia, Thailand and 6 more countries. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W24 (time frame: week 24). 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 23 Jan 2012.