Safety Study of Once a Day ART and Opiate Substitute.

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study looks at HIV-infected subjects who are on methadone treatment and medicines for HIV.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Tenofovir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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