NCT00324688

CompletedPhase 4

Safety Study of Once a Day ART and Opiate Substitute.

NCT00324688|CompletedPhase 4

Safety Study of Once a Day ART and Opiate Substitute.

3OD

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

Gilead Sciences

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

GS-MC-104-1015

Secondary identifiers

GS-02-1015

Study Type

interventional

Reported enrollment (type unavailable)

60

Locations

1 country

Sites

1

Timeline

Study Start

March 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

June 2006

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 60 participants
Study completion date: June 2006
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2003
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
May 10, 2006
Actual (reported)
First Posted
May 11, 2006
Actual (reported)
Study Completion
June 2006
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: March 12, 2014
Status Verified: March 2014
Last Update Submitted: March 11, 2014

Conditions

HIV Infections

Keywords

HIV-1MethadoneHIV-1 infection

Outcome Measures

Primary Outcomes (1)

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
+8 more secondary outcomes

Interventions

VireadDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ages 18 years or older
Previously documented diagnosis of HIV-1 infection:

Sponsors & Collaborators

Gilead Sciences
Industrylead

Study Sites (1)

Gilead Sciences

Munich, Germany

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency Syndromes

Study Officials

Thomas Mertenskoetter
Gilead Sciences
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 11, 2006

Study Start

March 2003

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

June 2006

Date type not reported

Completed

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Phase 4Completed

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Phase 4Completed

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Phase 4Completed

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Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients

Phase 4Completed

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Alternative Dosing Strategy for Anti-HIV Drugs

Phase 4Completed

NCT00323492

TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada

Phase 4Completed

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

+1 more criteria

You may not qualify if:

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
+2 more criteria

Contact the study team to confirm eligibility.

Immune System Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

This date has not been verified as actual or estimated.

Last Updated

March 12, 2014

Record last verified: 2014-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00324688
Data provider: ClinicalTrials.gov
Source updated: 2014-03-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:10 UTC

Locations

DE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations