HIV InfectionsPhase 4NCT00106379
Tenofovir DF (Disoproxil Fumarate) in Combination With Emtricitabine in HIV-1 Patients
A Phase 4 study testing Truvada (tenofovir DF + emtricitabine), Emtriva (emtricitabine) and Viread (tenofovir DF) in people with HIV Infections, run by Gilead Sciences at 4 sites in United States.
Trial summary
The purpose of this study is to provide long-term clinical safety and efficacy data for tenofovir disoproxil fumarate and emtricitabine in HIV-infected patients experiencing various degrees of renal impairment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Truvada (tenofovir DF + emtricitabine), Emtriva (emtricitabine) and Viread (tenofovir DF)
- How many people
- 52 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2004to Jan 2007
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for participation in the study.
- HIV-1 infection
- Either antiretroviral therapy-naive requiring antiretroviral treatment with HIV-1 RNA greater than 400 copies/mL or antiretroviral therapy-experienced on a stable antiretroviral regimen for at least 3 mos. with HIV-1 RNA less than or equal to 50 copies/mL at screening.
- No active opportunistic infection within 45 days prior to baseline.
- Able to understand and sign the informed consent form and comply with the study.
- Stable renal impairment within the four defined groups for at least 3 mos., based on creatinine clearance (Cockcroft-Gault method).
Who cannot join
- Patients who meet any of the following are not to be enrolled in this study.
- Women who are pregnant or breastfeeding
- Fanconi syndrome or multiple myeloma, tertiary hyperparathyroidism, malignancy (with the exception of basocellular carcinoma) or myeloproliferative disorder.
- Women of childbearing potential who are unwilling to use an effective contraceptive method during the study
- Contraindications to tenofovir DF, emtricitabine or efavirenz
- Undergoing treatment for tuberculosis
Show all 13Show fewer
- Using atazanavir
- Prior history of mutation M184V, K65R or T69 insertion
- Z-score on pre-baseline DEXA scan less than -2.5
- The following laboratory values within 30 days prior to study entry: *absolute neutrophil count (ANC) less than 750/mm3, *hemoglobin less than 9.0 g/dL, *platelet count less than 50,000/mm3, *AST (SGOT) or ALT (SGPT) less than 5 x ULN and *CD4 cell count less than 100/mm3.
- Use of nephrotoxic agents or competitors with renal excretions, including aminoglycoside antibiotics, intravenous amphotericin B, cidofovir, cisplatin, foscarnet, intravenous pentamidine, probenecid or other agents with significant nephrotoxic potential
- Clinically significant cardiac, pulmonary or gastrointestinal disorder
- Alcohol or drug abuse that could hinder compliance with the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Ronald Reisler, MD
Baltimore, Maryland, 21201
Gary Richmond, MD
Fort Lauderdale, Florida, 33316
Fernando Garcia, MD
Harlingen, Texas, 78550
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
About this study
Official title: A Phase 4, Single-Arm Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Tenofovir Disoproxil Fumarate in Combination With Emtricitabine in HIV-1 Infected Patients Experiencing Various Degrees of Renal Impairment
The purpose of this study is to provide long-term clinical safety and efficacy data for tenofovir disoproxil fumarate and emtricitabine in HIV-infected patients experiencing various degrees of renal impairment.
Read the detailed description
The primary objective of this study is as follows:
- To evaluate the safety and tolerability of tenofovir following administration of tenofovir disoproxil fumarate 300 mg for 48 weeks in HIV-infected patients experiencing various degrees of renal impairment.
The secondary objectives of this study are as follows:
- To evaluate the safety and tolerability of emtricitabine following administration of emtricitabine 200 mg for 48 weeks in HIV-infected patients experiencing various degrees of renal impairment.
- To evaluate the efficacy of tenofovir disoproxil fumarate in combination with emtricitabine in renally-impaired HIV-infected patients.
- To evaluate the pharmacokinetics of tenofovir and emtricitabine in renally-impaired HIV-infected patients.
- Conditions
- HIV Infections
- Being tested
- Truvada (tenofovir DF + emtricitabine), Emtriva (emtricitabine), Viread (tenofovir DF)
- Keywords
- HIV-1, Treatment Naive, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Truvada (tenofovir DF + emtricitabine)Drug
Emtriva (emtricitabine)Drug
Viread (tenofovir DF)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV-1 infection
Secondary outcomes (1)
HIV-1 infection in renally impaired HIV infected patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2005 (estimated)
- Study startOct 2004
- Study completionJan 2007
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
- 52 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106379
- Sponsor's protocol ID
- GS-104-0235
- Status last verified
- Apr 2008
- First submitted
- 23 Mar 2005
- Last updated
- 2 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Single-Arm Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Tenofovir Disoproxil Fumarate in Combination With Emtricitabine in HIV-1 Infected Patients Experiencing Various Degrees of Renal Impairment
- ClinicalTrials.gov ID
- NCT00106379
- Acronym / sponsor ID
- GS-104-0235
- Conditions
- HIV Infections
- Keywords
- HIV-1, Treatment Naive, Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Jan 2007 (actual)
- First posted
- 24 Mar 2005 (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.
The purpose of this study is to provide long-term clinical safety and efficacy data for tenofovir disoproxil fumarate and emtricitabine in HIV-infected patients experiencing various degrees of renal impairment.
Detailed description
The primary objective of this study is as follows:
- To evaluate the safety and tolerability of tenofovir following administration of tenofovir disoproxil fumarate 300 mg for 48 weeks in HIV-infected patients experiencing various degrees of renal impairment.
The secondary objectives of this study are as follows:
- To evaluate the safety and tolerability of emtricitabine following administration of emtricitabine 200 mg for 48 weeks in HIV-infected patients experiencing various degrees of renal impairment.
- To evaluate the efficacy of tenofovir disoproxil fumarate in combination with emtricitabine in renally-impaired HIV-infected patients.
- To evaluate the pharmacokinetics of tenofovir and emtricitabine in renally-impaired HIV-infected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must meet all of the following inclusion criteria to be eligible for participation in the study.
- HIV-1 infection
- Either antiretroviral therapy-naive requiring antiretroviral treatment with HIV-1 RNA greater than 400 copies/mL or antiretroviral therapy-experienced on a stable antiretroviral regimen for at least 3 mos. with HIV-1 RNA less than or equal to 50 copies/mL at screening.
- No active opportunistic infection within 45 days prior to baseline.
- Able to understand and sign the informed consent form and comply with the study.
Key exclusion criteria (13 listed)
- Patients who meet any of the following are not to be enrolled in this study.
- Women who are pregnant or breastfeeding
- Fanconi syndrome or multiple myeloma, tertiary hyperparathyroidism, malignancy (with the exception of basocellular carcinoma) or myeloproliferative disorder.
- Women of childbearing potential who are unwilling to use an effective contraceptive method during the study
- Contraindications to tenofovir DF, emtricitabine or efavirenz
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 |
|---|---|---|
| Truvada (tenofovir DF + emtricitabine) | Drug | – |
| Emtriva (emtricitabine) | Drug | – |
| Viread (tenofovir DF) | Drug | – |
Primary outcome
HIV-1 infection
1 secondary outcome
HIV-1 infection in renally impaired HIV infected patients
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 2 Feb 2010.
- Truvada websiteLink provided by the sponsor.
- Gilead websiteLink provided by the sponsor.
- Viread websiteLink provided by the sponsor.
- Study ResultsLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Truvada (tenofovir DF + emtricitabine), Emtriva (emtricitabine) and Viread (tenofovir DF) in people with HIV Infections, run by Gilead Sciences at 4 sites in United States.
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 6 inclusion and 13 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 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
HIV-1 infection. 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 2 Feb 2010.