Status:
COMPLETED
Safety Study of Once a Day ART and Opiate Substitute.
Lead Sponsor:
Gilead Sciences
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study looks at HIV-infected subjects who are on methadone treatment and medicines for HIV.
Detailed Description
Patients with a history of opiate abuse (IVDU) are not only a patient population that is frequently difficult to reach by the healthcare system, but it also exhibits specific problems in HIV-treatment...
Eligibility Criteria
Inclusion
- Ages 18 years or older
- Previously documented diagnosis of HIV-1 infection:
- by antibody assay (enzyme immunoassay confirmed by western immunoblot); or
- positive HIV culture; or
- detectable plasma HIV-1-RNA levels by reverse transcriptase polymerase chain reaction (RT-PCR).
- Receiving stable opiate substitution (stable methadone level for ≥ 2 weeks prior to entry into the study) with methadone, levomethadone or buprenorphine
- Either:
- Antiretroviral (ARV) therapy-naïve(\*) and with:
- CD4 counts \< 351 cells/µL; and/or
- HIV-1 plasma levels \>= 30,000 copies/mL (\*)less than 3 months of ART for vertical transmission is considered as ARV therapy naïve.
- Or restarting ART after treatment discontinuation with no evidence of prior HIV virological failure (virological failure defined as 2 consecutive measurements 4 weeks apart with viral load of HIV RNA \> 400 copies/mL while on ART)
- Or currently receiving stable ART therapy and with virological suppression (\< 400 copies/mL), for at least 6 months and:
- suffering from adherence problems because of dosing of current ART; or
- suffering from side effects on the current recorded ART.
- Able to give informed consent
- In the opinion of the investigator is likely to be able to complete the study
Exclusion
- Need for antiretroviral therapy which is not according to protocol
- Pregnant or breastfeeding women
- Females of childbearing potential not willing to use a barrier method(s) of contraception during heterosexual intercourse during the duration of the study
- Contraindication to use of tenofovir DF 300 mg or another concomitant medication
- Known hypersensitivity to the active component or excipients
- Prior receipt of tenofovir
- Evidence of clinical, genotypic, or phenotypic resistance to any ARV
- History of virological failure while on previously recorded ART regimens (virological failure defined as 2 consecutive measurements 4 weeks apart with viral load of HIV RNA \> 400 copies/mL)
- Acute, life-threatening infection or malignancy that needs systemic therapy
- Any clinical laboratory findings obtained during screening that could be a risk factor for the patient during the study:
- Grade 4 increase of any laboratory value
- Grade 3 (\> 5-10 upper limit of normal \[ULN\] increase in transaminases) at the screening visit
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
- Current use of medication that, in the investigator's opinion or sponsor's opinion, will interfere with the study medication
- Participation in other clinical trials
- More than three months of ART treatment for vertical transmission prophylaxis
- Current receipt of adefovir dipivoxil
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00324688
Start Date
March 1 2003
End Date
June 1 2006
Last Update
March 12 2014
Active Locations (1)
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1
Gilead Sciences
Munich, Germany