A Long Term Safety Study of Apricitabine in HIV-infected Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00686270 |
Recruitment Status
:
Withdrawn
(Study was withdrawn owing to Sponsor decision)
First Posted
: May 29, 2008
Last Update Posted
: June 23, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: apricitabine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Open Label 96-week Extension Study of the Safety of Apricitabine in Treatment-experienced HIV-1 Infected Patients Who Have Completed Protocol AVX-301 or AVX-302 or Who Have Met the Criteria for Open-label Access to ATC Because of Virological Failure/Lack of Response |
Study Start Date : | May 2008 |
Estimated Primary Completion Date : | May 2012 |
Estimated Study Completion Date : | May 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
apricitabine
|
Drug: apricitabine
Initially 1200mg apricitabine twice daily orally. Following the determination of the optimum dose (800mg or 1200mg twice daily) in the pre-ceeding study AVX-301,patients may be switched to the optimum dose,if required.
Other Names:
|
- The number, type and severity of SAEs occuring during the study [ Time Frame: Week 96 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who complete studies AVX-301 or AVX-302 or :Patients who meet the criteria for virologic failure/lack of response in study AVX-301 or AVX-302
- 18 years of age, or older
- Male, or non-pregnant, non-breastfeeding female patients, who agree to comply with the applicable contraceptive requirements of the protocol.
Exclusion Criteria:
- Prior withdrawal from AVX-301 or AVX-302
- Current acute or chronic hepatitis B virus infection
- Current treatment for hepatitis C virus infection
- Renal Function not adequate

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686270
Principal Investigator: | Mike Saag, Professor | UAB Centre for AIDS Research, Birmingham, Alabama, 35294-2050, USA | |
Study Director: | Susan W Cox, PhD | Avexa Ltd |
Responsible Party: | Susan Cox, Avexa Ltd |
ClinicalTrials.gov Identifier: | NCT00686270 History of Changes |
Other Study ID Numbers: |
AVX-303 |
First Posted: | May 29, 2008 Key Record Dates |
Last Update Posted: | June 23, 2011 |
Last Verified: | June 2011 |
Keywords provided by Avexa:
HIV-1 infection NRTI resistance M184V mutation reverse transcriptase apricitabine |
drug resistance safety and tolerability therapy failure Treatment Experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |