HIVPhase 4NCT00344461
A Two Year Study of the Clinical Efficacy of the Combination of Emtricitabine, Tenofovir, and Nevirapine
A Phase 4 study testing Nevirapine, FTC, and Tenofovir in people with HIV, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Open label, two year study of the clinical efficacy of the combination of FTC, Tenofovir, and Nevirapine. Sixty HIV infected patients without previous exposure to antiretroviral therapy will be enrolled. Study will include a pharmacokinetic substudy to evaluate the interaction of FTC and Nevirapine. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HIV
- What is being tested?
- Nevirapine, FTC, and Tenofovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jul 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infection, as documented by any licensed ELISA test kit, and confirmed by Western blot, positive HIV-1 blood culture, positive HIV serum antigen, or plasma viremia at any time prior to study entry. If no record exists, testing must occur at screening.
- Male or female, age 18 to 75 years of age.
- Able to sign the informed consent, and is willing to comply with the requirements of this clinical trial.
- Available for at least 96 weeks of follow up.
- Males: deemed a candidate for antiretroviral therapy per referring primary care provider. (If patient is self referred, CD4 cell count must be <400 cells/mm3 and viral load>5,000c/ml) Females: CD4 cell count must be less than 250 cells/mm3 and viral load >5,000 c/mL at time of enrollment.
- If female and of child bearing potential must consent to using at least two forms of contraception.
- Participants will be "treatment naive" as no prior antiretroviral therapy or antiretroviral therapy for less than 7 days in the past.
Who cannot join
- Evidence of mutation associated with primary drug resistance to Nevirapine (K103N, Y181C, Y188L, G190S), Tenofovir (M41L, T69 insertion, Q151M, L210W,and K65R), and/or FTC (184V) previously documented, or at time of screening.
- Patients with any of the following laboratory parameters at the screening visit: estimated creatinine clearance of <60 ml/min; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limits of normal; total bilirubin >1.5 mg/dL.
- Women with CD4 cell count > 250 cells/ mm3 at time of entry or in males with a CD4 cell count less than 400/mm3, along with a viral load greater than 5,000c/ml. for both males and females.
- Pregnant women or women who are breast feeding.
- Unwillingness to use effective barrier contraception.
- Patients with current alcohol abuse or illicit drug use that in the opinion of the Principal Investigator may interfere with the patient's ability to comply with the protocol requirements.
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- Patients with malabsorption or severe chronic diarrhea for more than 30 days.
- Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- History of any chronic illness or other condition that in the opinion of the investigator would interfere with the conduct or completion of the study.
- Patient who is, in the opinion of the investigator, unable to complete the 96-week dosing period and protocol evaluations and assessments.
- Experimental vaccines, to include HIV vaccines.
- Patient who is currently enrolled in an experimental protocol, or is receiving an experimental medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201
About this study
Official title: Cell Cycle Independent Antiretroviral Therapy: Combination of Nevirapine, FTC, and Tenofovir
Open label, two year study of the clinical efficacy of the combination of FTC, Tenofovir, and Nevirapine. Sixty HIV infected patients without previous exposure to antiretroviral therapy will be enrolled. Study will include a pharmacokinetic substudy to evaluate the interaction of FTC and Nevirapine. Truvada may be used.
Read the detailed description
Description of study design This is an open-labeled clinical trial evaluating an antiretroviral treatment regimen in which the drugs have demonstrated in vitro activity in both, resting and activated mononuclear cells. These drugs include: FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d.
Eligible patients must be at least 18 years of age, be referred by their primary HIV provider for antiretroviral therapy or if the patient is self referred, have a cluster of differentiation 4 (CD4) cell count of < 250/mm3 and have a viral load >5,000c/ml. Eligibility requirement for women is that they must have a CD4 cell count of <250 at the time of enrollment. This cutoff for women is based on unpublished data that there may be increased hepatotoxicity in women with a CD4 cell count > 250 cell/mm3. The screening evaluation will take place the day the informed consent is signed. During that screening evaluation, the patient will undergo a history and physical examination, and will have study labs drawn. Within 60 days of the screening evaluation and meeting all eligible criteria, the patient will be placed on the study treatment regimen. Patients will be evaluated at the clinic on Day 0 (therapy initiation), weeks 2, 4, 6, 8, 12, 16, and then every 8 weeks until 48 weeks and thereafter every 12 weeks through week 96. At the end of the study, all patients may continue their current antiretroviral treatment regimen at the discretion of the patient and their primary care provider.
Pharmacokinetic Analysis Sub Study A pharmacokinetic evaluation will be performed in first 7 volunteers to assess the impact of FTC on Nevirapine and vice versa. Pharmacokinetic analysis will be performed at end of week 2 ( day 14) during 200mg qd start up period. Samples will be obtained at baseline and 1, 3, 6, 12 and 24 hours post Nevirapine dosing. Pharmacokinetic analysis will be repeated at the week 8 visit. Samples will be obtained at baseline and 1, 3, 6, 12 and 24 hours post Nevirapine.
Assignment of patients There will be 60 patients involved in this clinical trial. This is an open-labeled study. There are no placebos involved in this study.
Dose and dose selection The dosages of medications are those that are currently used as standard clinical practice: Nevirapine 200 mg b.i.d. (1-200 mg tablet b.i.d.); Emtricitabine (FTC) 200mg po qd.(1-200mg capsule); Tenofovir 300 mg once-a-day (1-300 mg tablet qd).
Justification of study design All study patients require treatment for their HIV infection. All of the drugs used in this study are FDA-Approved. Tenofovir and FTC are approved as a once-a-day treatment medication. Nevirapine (NVP) is approved for BID dosing.
NOTE: That whenever Nevirapine is being prescribed, there will be a lead-in period of 14 days in which Nevirapine will be prescribed as 200 mg once a day followed by 200 mg BID as is the recommended standard of care.
- Conditions
- HIV
- Being tested
- Nevirapine, FTC, and Tenofovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nevirapine, FTC, and TenofovirDrug
One arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| Nevirapine, FTC, Tenofovir | Experimental | Open Label Drugs- Nevirapine 200 mg twice a day, FTC 200 mg once a day and Tenofovir 300 mg once a day for 96 weeks. Receives: Drug: Nevirapine, FTC, and Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Sustained Virologic Response
The primary outcome is sustained Virologic response, defined as HIV-1 RNA <500 copies/mL until trial completion at 96 weeks.
Measured: 96 Weeks
Secondary outcomes (5)
Patients With Grade 2, 3 and 4 Adverse Events and Laboratory Toxicities
The number of participants with grades 2,3 and 4 adverse events and laboratory toxicities.
Measured: Protocol length is 96 weeks
Patients With Plasma HIV RNA < 50 Copies/mL
The number of participants with plasma HIV RNA < 50 copies/mL
Measured: 96 weeks.
Patients With Plasma HIV RNA < 400 Copies/mL
The number of participants with plasma HIV RNA < 400 copies/mL
Measured: 96 weeks
Change in Plasma HIV RNA From Baseline to Week 96
Percent Change From Baseline in Plasma HIV RNA at 96 weeks
Measured: Baseline to week 96
Changes in CD4 Cell Count From Baseline and Week 96
To determine the mean change from Baseline in CD4 cell count to week 96.
Measured: Baseline to week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2006 (estimated)
- Study startMar 2004
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Robert R Redfield, MD, Principal investigator, University of Maryland, School of Medicine, IHVCharles E Davis, MD, Principal investigator, University of Maryland, School of Medicine, IHV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344461
- Sponsor's protocol ID
- H-23783
- Status last verified
- Oct 2021
- First submitted
- 22 Jun 2006
- Last updated
- 1 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Amoroso A, Gilliam BL, Talwani R, Boyce C, Redfield RR, Davis CE. Viral load decay in antiretroviral-naive patients receiving once-daily tenofovir and emtricitabine plus twice-daily nevirapine. HIV Clin Trials. 2009 Sep-Oct;10(5):320-3. doi: 10.1310/hct1005-320.
PubMed 19906624
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Cycle Independent Antiretroviral Therapy: Combination of Nevirapine, FTC, and Tenofovir
- ClinicalTrials.gov ID
- NCT00344461
- Acronym / sponsor ID
- H-23783
- Conditions
- HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Mar 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 26 Jun 2006 (estimated)
- Results
- Posted 14 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open label, two year study of the clinical efficacy of the combination of FTC, Tenofovir, and Nevirapine. Sixty HIV infected patients without previous exposure to antiretroviral therapy will be enrolled. Study will include a pharmacokinetic substudy to evaluate the interaction of FTC and Nevirapine. Truvada may be used.
Detailed description
Description of study design This is an open-labeled clinical trial evaluating an antiretroviral treatment regimen in which the drugs have demonstrated in vitro activity in both, resting and activated mononuclear cells. These drugs include: FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d.
Eligible patients must be at least 18 years of age, be referred by their primary HIV provider for antiretroviral therapy or if the patient is self referred, have a cluster of differentiation 4 (CD4) cell count of < 250/mm3 and have a viral load >5,000c/ml. Eligibility requirement for women is that they must have a CD4 cell count of <250 at the time of enrollment. This cutoff for women is based on unpublished data that there may be increased hepatotoxicity in women with a CD4 cell count > 250 cell/mm3. The screening evaluation will take place the day the informed consent is signed. During that screening evaluation, the patient will undergo a history and physical examination, and will have study labs drawn. Within 60 days of the screening evaluation and meeting all eligible criteria, the patient will be placed on the study treatment regimen. Patients will be evaluated at the clinic on Day 0 (therapy initiation), weeks 2, 4, 6, 8, 12, 16, and then every 8 weeks until 48 weeks and thereafter every 12 weeks through week 96. At the end of the study, all patients may continue their current antiretroviral treatment regimen at the discretion of the patient and their primary care provider.
Pharmacokinetic Analysis Sub Study A pharmacokinetic evaluation will be performed in first 7 volunteers to assess the impact of FTC on Nevirapine and vice versa. Pharmacokinetic analysis will be performed at end of week 2 ( day 14) during 200mg qd start up period. Samples will be obtained at baseline and 1, 3, 6, 12 and 24 hours post Nevirapine dosing. Pharmacokinetic analysis will be repeated at the week 8 visit. Samples will be obtained at baseline and 1, 3, 6, 12 and 24 hours post Nevirapine.
Assignment of patients There will be 60 patients involved in this clinical trial. This is an open-labeled study. There are no placebos involved in this study.
Dose and dose selection The dosages of medications are those that are currently used as standard clinical practice: Nevirapine 200 mg b.i.d. (1-200 mg tablet b.i.d.); Emtricitabine (FTC) 200mg po qd.(1-200mg capsule); Tenofovir 300 mg once-a-day (1-300 mg tablet qd).
Justification of study design All study patients require treatment for their HIV infection. All of the drugs used in this study are FDA-Approved. Tenofovir and FTC are approved as a once-a-day treatment medication. Nevirapine (NVP) is approved for BID dosing.
NOTE: That whenever Nevirapine is being prescribed, there will be a lead-in period of 14 days in which Nevirapine will be prescribed as 200 mg once a day followed by 200 mg BID as is the recommended standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nevirapine, FTC, Tenofovir | Experimental | Drug: Nevirapine, FTC, and TenofovirOpen Label Drugs- Nevirapine 200 mg twice a day, FTC 200 mg once a day and Tenofovir 300 mg once a day for 96 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV-1 infection, as documented by any licensed ELISA test kit, and confirmed by Western blot, positive HIV-1 blood culture, positive HIV serum antigen, or plasma viremia at any time prior to study entry. If no record exists, testing must occur at screening.
- Male or female, age 18 to 75 years of age.
- Able to sign the informed consent, and is willing to comply with the requirements of this clinical trial.
- Available for at least 96 weeks of follow up.
- Males: deemed a candidate for antiretroviral therapy per referring primary care provider. (If patient is self referred, CD4 cell count must be <400 cells/mm3 and viral load>5,000c/ml) Females: CD4 cell count must be less than 250 cells/mm3 and viral load >5,000 c/mL at time of enrollment.
Key exclusion criteria (12 listed)
- Evidence of mutation associated with primary drug resistance to Nevirapine (K103N, Y181C, Y188L, G190S), Tenofovir (M41L, T69 insertion, Q151M, L210W,and K65R), and/or FTC (184V) previously documented, or at time of screening.
- Patients with any of the following laboratory parameters at the screening visit: estimated creatinine clearance of <60 ml/min; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limits of normal; total bilirubin >1.5 mg/dL.
- Women with CD4 cell count > 250 cells/ mm3 at time of entry or in males with a CD4 cell count less than 400/mm3, along with a viral load greater than 5,000c/ml. for both males and females.
- Pregnant women or women who are breast feeding.
- Unwillingness to use effective barrier contraception.
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 |
|---|---|---|
| Nevirapine, FTC, and TenofovirOne arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d. | Drug | Nevirapine, FTC, Tenofovir |
Primary outcome
Number of Participants With Sustained Virologic Response
Time frame: 96 Weeks
The primary outcome is sustained Virologic response, defined as HIV-1 RNA <500 copies/mL until trial completion at 96 weeks.
5 secondary outcomes
Patients With Grade 2, 3 and 4 Adverse Events and Laboratory Toxicities
Time frame: Protocol length is 96 weeks
Patients With Plasma HIV RNA < 50 Copies/mL
Time frame: 96 weeks.
Patients With Plasma HIV RNA < 400 Copies/mL
Time frame: 96 weeks
Change in Plasma HIV RNA From Baseline to Week 96
Time frame: Baseline to week 96
Changes in CD4 Cell Count From Baseline and Week 96
Time frame: Baseline to week 96
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19906624Amoroso A, Gilliam BL, Talwani R, Boyce C, Redfield RR, Davis CE. Viral load decay in antiretroviral-naive patients receiving once-daily tenofovir and emtricitabine plus twice-daily nevirapine. HIV Clin Trials. 2009 Sep-Oct;10(5):320-3. doi: 10.1310/hct1005-320.
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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.
Robert R Redfield, MD principal investigator
University of Maryland, School of Medicine, IHV
Charles E Davis, MD principal investigator
University of Maryland, School of Medicine, IHV
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 Nevirapine, FTC, and Tenofovir in people with HIV, run by University of Maryland, Baltimore at 1 site 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 7 inclusion and 12 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 1 Nov 2021. 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 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?
Yes. Results are posted in the registry (first posted 14 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Sustained Virologic Response (time frame: 96 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00344461, which also lists 1 linked publication.
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 1 Nov 2021.