Overview

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