HIV InfectionsPhase 43ODNCT00324688
Safety Study of Once a Day ART and Opiate Substitute.
A Phase 4 study testing Viread in people with HIV Infections, run by Gilead Sciences at 1 site in Germany.
Trial summary
This study looks at HIV-infected subjects who are on methadone treatment and medicines for HIV. 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?
- Viread
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2003to Jun 2006
- Phase
- Phase 4
- 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
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Multicenter Study to Assess the Efficacy, the Tolerability and the Adherence of a Once Daily (QD) Taken Antiretroviral Therapy (ART) Containing the NtRTI Tenofovir DF 300 mg in Combination With the Best Suitable Once a Day Regimen Being 1 NRTI Plus 1 PI or 1 NRTI Plus 1 NNRTI in HIV-1-infected IVDU- Patients With Opiate Substitution Being Either Antiretroviral-naive or With Suppressed Viral Load and Without a History of Virological Failure
This study looks at HIV-infected subjects who are on methadone treatment and medicines for HIV.
Read the 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 (ART). These patients frequently have a chaotic lifestyle, which makes it difficult to take medications regularly. Amongst the reasons for this are housing difficulties, intoxication and substance abuse.
The introduction of opiate substitution treatment can help to provide some structure and certainty to patients. Even so IVDU patients are often started on ART later than others and have a greater tendency to have treatment interruptions and sub-optimal adherence to ART. The end result can be treatment failure and the development of drug resistance.
There is an unmet medical need for ART regimens that make adherence easier and may be suitable for co-administration with once-daily opiate substitution.
The availability of tenofovir disoproxil fumarate (DF) 300 mg offers new options in the creation of once-daily regimens with reduced potential for drug-drug-interactions. It is believed that it is now possible to construct viable once daily HIV treatment regimens for patients who have either never received prior therapy or who have no history of drug resistance. Tenofovir DF is administered as a single 300 mg tablet once daily with food for the treatment of HIV infection. This once daily dosing schedule of tenofovir DF makes it an attractive option for simplified dosing regimens in many subjects, including methadone-maintained individuals infected with HIV. Because many opiate-maintained subjects are required to have their methadone dosing directly observed in the clinic, there is considerable interest in using directly-observed therapy (DOT) in such subjects. Given that tenofovir is eliminated renally and methadone is predominantly hepatically metabolized, the potential for a pharmacokinetic interaction is low. However, other antiretroviral agents with substantial renal elimination such as didanosine and stavudine have been shown to interact pharmacokinetically with methadone. Thus, it is important to demonstrate that tenofovir DF and methadone can be administered together safely and without concern for a pharmacokinetic interaction and/or alterations in the efficacy, safety, or tolerability of methadone maintenance such that dose modifications would be required. This can also be influenced by the other products in the combination therapy.
HIV/HBV coinfection is a frequent issue in this population (> 20%). Treatment with TDF, which is active against HBV, could help to stabilize the chronic HBV infection, even in cases with Lamivudine-resistance.
- Conditions
- HIV Infections
- Being tested
- Viread
- Keywords
- HIV-1, Methadone, HIV-1 infection
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VireadDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week 48
Secondary outcomes (13)
Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week 24
Time to failure or ART discontinuation. Virological failure is defined as 2 consecutive measurements 4 weeks apart with viral load of HIV RNA > 400 copies/mL
Adherence to HIV treatments (Medication Adherence Self-Report Inventory [MASRI] questionnaire, monthly evaluation through patient diary)
Adherence to opiate substitution treatment
Correlation of adherence to ART and HIV RNA levels
Percentage of patients with HIV-1 RNA below limit of detection < 400 copies/mL and 50 copies/mL and adherence level > 95%, > 90%, > 85%, > 80%, > 75%, > 70%, > 50% and < 50%
Dose adjustments for methadone
Proportion of patients with any adverse event (AE)/serious adverse event (SAE)
Proportion of patients with AE/SAE classified by body system
Proportion of patients with each AE/SAE
Distribution of intensity of each AE/SAE (the highest intensity per patient for each event will be considered)
Distribution of relationship to study drug (the strongest relationship to study drug per patient for each event will be considered)
Distribution of toxicity grade (the highest grade per patient for each test will be considered)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2006 (estimated)
- Study startMar 2003
- Study completionJun 2006
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.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Mertenskoetter, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324688
- Sponsor's protocol ID
- GS-MC-104-1015
- Other IDs
- GS-02-1015
- Acronym
- 3OD
- Status last verified
- Mar 2014
- First submitted
- 10 May 2006
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Multicenter Study to Assess the Efficacy, the Tolerability and the Adherence of a Once Daily (QD) Taken Antiretroviral Therapy (ART) Containing the NtRTI Tenofovir DF 300 mg in Combination With the Best Suitable Once a Day Regimen Being 1 NRTI Plus 1 PI or 1 NRTI Plus 1 NNRTI in HIV-1-infected IVDU- Patients With Opiate Substitution Being Either Antiretroviral-naive or With Suppressed Viral Load and Without a History of Virological Failure
- ClinicalTrials.gov ID
- NCT00324688
- Acronym / sponsor ID
- 3OD / GS-MC-104-1015
- Conditions
- HIV Infections
- Keywords
- HIV-1, Methadone, HIV-1 infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Study completion
- Jun 2006
- First posted
- 11 May 2006 (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.
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 (ART). These patients frequently have a chaotic lifestyle, which makes it difficult to take medications regularly. Amongst the reasons for this are housing difficulties, intoxication and substance abuse.
The introduction of opiate substitution treatment can help to provide some structure and certainty to patients. Even so IVDU patients are often started on ART later than others and have a greater tendency to have treatment interruptions and sub-optimal adherence to ART. The end result can be treatment failure and the development of drug resistance.
There is an unmet medical need for ART regimens that make adherence easier and may be suitable for co-administration with once-daily opiate substitution.
The availability of tenofovir disoproxil fumarate (DF) 300 mg offers new options in the creation of once-daily regimens with reduced potential for drug-drug-interactions. It is believed that it is now possible to construct viable once daily HIV treatment regimens for patients who have either never received prior therapy or who have no history of drug resistance. Tenofovir DF is administered as a single 300 mg tablet once daily with food for the treatment of HIV infection. This once daily dosing schedule of tenofovir DF makes it an attractive option for simplified dosing regimens in many subjects, including methadone-maintained individuals infected with HIV. Because many opiate-maintained subjects are required to have their methadone dosing directly observed in the clinic, there is considerable interest in using directly-observed therapy (DOT) in such subjects. Given that tenofovir is eliminated renally and methadone is predominantly hepatically metabolized, the potential for a pharmacokinetic interaction is low. However, other antiretroviral agents with substantial renal elimination such as didanosine and stavudine have been shown to interact pharmacokinetically with methadone. Thus, it is important to demonstrate that tenofovir DF and methadone can be administered together safely and without concern for a pharmacokinetic interaction and/or alterations in the efficacy, safety, or tolerability of methadone maintenance such that dose modifications would be required. This can also be influenced by the other products in the combination therapy.
HIV/HBV coinfection is a frequent issue in this population (> 20%). Treatment with TDF, which is active against HBV, could help to stabilize the chronic HBV infection, even in cases with Lamivudine-resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Ages 18 years or older
- Previously documented diagnosis of HIV-1 infection:
- Receiving stable opiate substitution (stable methadone level for ≥ 2 weeks prior to entry into the study) with methadone, levomethadone or buprenorphine
- Either:
- Able to give informed consent
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| Viread | Drug | – |
Primary outcome
Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week 48
13 secondary outcomes
Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week 24
Time to failure or ART discontinuation. Virological failure is defined as 2 consecutive measurements 4 weeks apart with viral load of HIV RNA > 400 copies/mL
Adherence to HIV treatments (Medication Adherence Self-Report Inventory [MASRI] questionnaire, monthly evaluation through patient diary)
Adherence to opiate substitution treatment
Correlation of adherence to ART and HIV RNA levels
Percentage of patients with HIV-1 RNA below limit of detection < 400 copies/mL and 50 copies/mL and adherence level > 95%, > 90%, > 85%, > 80%, > 75%, > 70%, > 50% and < 50%
Dose adjustments for methadone
Proportion of patients with any adverse event (AE)/serious adverse event (SAE)
Proportion of patients with AE/SAE classified by body system
Proportion of patients with each AE/SAE
Distribution of intensity of each AE/SAE (the highest intensity per patient for each event will be considered)
Distribution of relationship to study drug (the strongest relationship to study drug per patient for each event will be considered)
Distribution of toxicity grade (the highest grade per patient for each test will be considered)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
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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.
Thomas Mertenskoetter study director
Gilead Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Viread in people with HIV Infections, run by Gilead Sciences at 1 site in Germany.
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 16 inclusion and 17 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: finished, as of the sponsor's last update on 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week 48. 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 12 Mar 2014.