HIV InfectionsPhase 3NCT00819052
Switching Nevirapine Immediate Release( IR) Based Regimen to Nevirapine Extended Release (XR) Based Regimen in Human Immunodeficiency Virus One (HIV-1) Infected Patients
A Phase 3 study testing Nevirapine XR and Nevirapine IR in people with HIV Infections, run by Boehringer Ingelheim at 39 sites in 4 countries.
Trial summary
The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy. 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?
- Nevirapine XR and Nevirapine IR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 445 participants
- Where
- 39 sitesin 4 countries
- Study dates
- Dec 2008to Jan 2012
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected subjects treated with a Viramune based regimen.
- A subject that meets the following inclusion criteria will be eligible for participation in this study:
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
- HIV-1 infected males or females of at least 18 years.
- Treatment with Viramune regimen for at least the preceding 18 weeks.
- Background therapy with lamivudine/ abacavir(3TC/ABC) (Kivexa® in EU; Epzicom in US), emtricitabine/tenofovir( FTC/TDF) (Truvada) or lamivudine/zidovudine 3TC/AZT (Combivir®).
Show all 11Show fewer
- An HIV viral load < 50 copies/mL in preceding 3 months.
- An HIV viral load of < 50 copies/mL at screening (Visit 1).
- Acceptable screening laboratory values that indicate adequate baseline organ function with the following exceptions: alanine aminotrnasferase (ALT) and asparatate aminotransferase (AST) < 2.5 × upper limit of normal (ULN) Division of Acquired Immunodeficiency Syndrome (DAIDS Grade 1).
- Willingness to abstain from ingesting medications that are listed as contraindicated in the Summary of Product Characteristics (SPC) or package insert (or PI) or Investigator's Brochure during the study.
- Karnofsky performance score of < 70
Who cannot join
- Subjects who meet one or more of the following criteria will be excluded from the study:
- Current treatment with an HIV protease inhibitor
- Participation in another trial or use of an investigational medicine within two months prior to Day 1 of this study
- Female patients of child-bearing potential who:
- Have a positive serum pregnancy test at screening.
- Are breast feeding.
Show all 15Show fewer
- Are planning to become pregnant
- Are not willing to use a double-barrier methods (simultaneous use of two different methods such as diaphragm with spermicidal substance and condom) of contraception, or require ethinyl estradiol administration. Barrier methods of contraception include diaphragm with spermicidal substance, condom for females, cervical caps and condoms..
- Laboratory parameters > DAIDS grade 2 Coagulation prothrombin time (PT), partial thromboplastin time (PTT), International Normalized ratio (INR) Hematology (absolute platelets, white blood cells (WBC), absolute neutrophil count, hemoglobin) Biochemistry (total bilirubin, amylase, serum creatinine, fasting glucose, lactate, alkaline phosphatase)
- Laboratory parameters > DAIDS grade 3 Total triglycerides (total cholesterol no restriction)
- Hypersensitivity to any ingredients of the test products
- Active drug abuse or chronic alcoholism.
- Hepatic cirrhosis stage Child-Pugh B or C
- History of severe or acute illness within 60 days prior to Day 1, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the trial
- Inability to comply with protocol requirements
Trial locations and contacts
39 sites in 4 countries.
39 sites in 4 countries
Germany15 sites
1100.1526.4902 Boehringer Ingelheim Investigational Site
Berlin
1100.1526.4903 Boehringer Ingelheim Investigational Site
Berlin
1100.1526.4904 Boehringer Ingelheim Investigational Site
Bochum
1100.1526.4905 Boehringer Ingelheim Investigational Site
Bonn
1100.1526.4907 Boehringer Ingelheim Investigational Site
Cologne
1100.1526.4914 Boehringer Ingelheim Investigational Site
Cologne
1100.1526.4906 Boehringer Ingelheim Investigational Site
Düsseldorf
1100.1526.4909 Boehringer Ingelheim Investigational Site
Frankfurt
1100.1526.4908 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1100.1526.4901 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
1100.1526.4910 Boehringer Ingelheim Investigational Site
Hamburg
1100.1526.4911 Boehringer Ingelheim Investigational Site
Hamburg
1100.1526.4912 Boehringer Ingelheim Investigational Site
Hamburg
1100.1526.4913 Boehringer Ingelheim Investigational Site
Hanover
1100.1526.4915 Boehringer Ingelheim Investigational Site
München
United States11 sites
1100.1526.1007 Boehringer Ingelheim Investigational Site
Austin, Texas
1100.1526.1003 Boehringer Ingelheim Investigational Site
Berkley, Michigan
1100.1526.1012 Boehringer Ingelheim Investigational Site
Beverly Hills, California
1100.1526.1014 Boehringer Ingelheim Investigational Site
Beverly Hills, California
1100.1526.1006 Boehringer Ingelheim Investigational Site
Clearwater, Florida
1100.1526.1011 Boehringer Ingelheim Investigational Site
Long Beach, California
1100.1526.1013 Boehringer Ingelheim Investigational Site
Los Angeles, California
1100.1526.1002 Boehringer Ingelheim Investigational Site
Miami, Florida
1100.1526.1005 Boehringer Ingelheim Investigational Site
Miami Beach, Florida
1100.1526.1001 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia
1100.1526.1004 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia
France9 sites
1100.1526.3306A Boehringer Ingelheim Investigational Site
Bobigny
1100.1526.3311A Boehringer Ingelheim Investigational Site
Bordeaux
1100.1526.3307A Boehringer Ingelheim Investigational Site
La Roche-sur-Yon
1100.1526.3312A Boehringer Ingelheim Investigational Site
Le Kremlin-Bicêtre
1100.1526.3301A Boehringer Ingelheim Investigational Site
Lyon
1100.1526.3310A Boehringer Ingelheim Investigational Site
Marseille
1100.1526.3308A Boehringer Ingelheim Investigational Site
Montpellier
1100.1526.3302A Boehringer Ingelheim Investigational Site
Nantes
1100.1526.3304A Boehringer Ingelheim Investigational Site
Nice
United Kingdom4 sites
1100.1526.4403 Boehringer Ingelheim Investigational Site
London
1100.1526.4405 Boehringer Ingelheim Investigational Site
London
1100.1526.4404 Boehringer Ingelheim Investigational Site
Manchester
1100.1526.4402 Boehringer Ingelheim Investigational Site
Tooting, London
About this study
Official title: An Open Label, Phase IIIb, Randomised Parallel Group Study to Assess the Efficacy and Safety of Switching HIV-1 Infected Patients Successfully Treated With a Nevirapine IR Based Regiment to Nevirapine XR 400 mg QD or Remaining on Nevirapine IR 200 mg BID Based Program
The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy.
- Conditions
- HIV Infections
- Being tested
- Nevirapine XR, Nevirapine IR
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nevirapine XRDrug
Nevirapine XR
Nevirapine XRDrug
Nevirapine extended release
Nevirapine IRDrug
Nevirapine Immediate Release
| Study group | Role | What they receive |
|---|---|---|
| NVP IR | Active comparator | 200 mg orally twice a day (po BID) Receives: Drug: Nevirapine XR; Drug: Nevirapine IR |
| NVP XR | Experimental | 400 mg orally once a day (po QD) Receives: Drug: Nevirapine XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Primary endpoint was the number of patients with a sustained virologic response through week 24
Measured: week 24
Secondary outcomes (42)
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 2
Measured: week 2
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 4
Measured: week 4
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 8
Measured: week 8
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 12
Measured: week 12
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 24
Measured: week 24
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Measured: week 0 to 24
Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population
Measured: week 0
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population
Measured: baseline, week 2
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population
Measured: baseline, week 4
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population
Measured: baseline, week 8
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population
Measured: baseline, week 12
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population
Measured: baseline, week 24
Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population
Measured: baseline, week 24
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 48
Measured: week 48
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 60
Measured: week 60
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 72
Measured: week 72
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 84
Measured: week 84
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 96
Measured: week 96
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 108
Measured: week 108
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 120
Measured: week 120
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 132
Measured: week 132
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 144
Measured: week 144
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response at their last available visit
Measured: last available visit, up to 144 weeks
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population
Measured: baseline, week 48
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population
Measured: baseline, week 60
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population
Measured: baseline, week 72
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population
Measured: baseline, week 84
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population
Measured: baseline, week 96
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population
Measured: baseline, week 108
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population
Measured: baseline, week 120
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population
Measured: baseline, week 132
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population
Measured: baseline, week 144
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population
Measured: baseline, last available visit (up to 144 weeks)
Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144
Endpoint was the number of patients with a sustained virologic response through week 144
Measured: week 144
Change From Baseline in VL (HIV-1 Viral Load) at Each Visit
Measured: week 48, 60, 72, 84, 96, 108, 120, 132, 144, last available visit
Changes in Safety Parameters Related to Treatment
Occurence of investigations related to treatment
Measured: until week 144
Occurence of Rashes
drug-related rashes by severity
Measured: 144 weeks
Occurence of Hepatic Events
Measured: 144 weeks
New AIDS or AIDS-related Progression Event or Death
Measured: 144 weeks
Time to Loss of Virologic Response
Kaplan-Meier Estimates of time to loss of virologic response defined as the time between the start of treatment and the time of treatment failure, up to and including the time when the last patient was on treatment for 48 weeks.
Measured: 48 weeks
Genotypic Resistance Associated With Virologic Failure
Genotypic resistance associated with virologic failure.
This endpoint was not analysed due to lack of data.
Measured: 48 weeks
Trough Plasma Concentration
Trough plasma concentrations of Nevirapine at steady state after multiple oral administrations of Nevirapine treatments from day 1 (visit 2) to week 48 (visit 9).
Measured: Day 1 to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionJan 2012
- Study completionJan 2012
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.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819052
- Sponsor's protocol ID
- 1100.1526
- Other IDs
- 2008-004681-55, 2008
- Status last verified
- Nov 2014
- First submitted
- 7 Jan 2009
- Last updated
- 10 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase IIIb, Randomised Parallel Group Study to Assess the Efficacy and Safety of Switching HIV-1 Infected Patients Successfully Treated With a Nevirapine IR Based Regiment to Nevirapine XR 400 mg QD or Remaining on Nevirapine IR 200 mg BID Based Program
- ClinicalTrials.gov ID
- NCT00819052
- Acronym / sponsor ID
- 1100.1526
- Conditions
- HIV Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Jan 2009 (estimated)
- Results
- Posted 24 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NVP IR | Active comparator | Drug: Nevirapine XR, Drug: Nevirapine IR200 mg orally twice a day (po BID) |
| NVP XR | Experimental | Drug: Nevirapine XR400 mg orally once a day (po QD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- HIV infected subjects treated with a Viramune based regimen.
- A subject that meets the following inclusion criteria will be eligible for participation in this study:
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
- HIV-1 infected males or females of at least 18 years.
- Treatment with Viramune regimen for at least the preceding 18 weeks.
Key exclusion criteria (15 listed)
- Current treatment with an HIV protease inhibitor
- Participation in another trial or use of an investigational medicine within two months prior to Day 1 of this study
- Female patients of child-bearing potential who:
- Laboratory parameters > DAIDS grade 2 Coagulation prothrombin time (PT), partial thromboplastin time (PTT), International Normalized ratio (INR) Hematology (absolute platelets, white blood cells (WBC), absolute neutrophil count, hemoglobin) Biochemistry (total bilirubin, amylase, serum creatinine, fasting glucose, lactate, alkaline phosphatase)
- Laboratory parameters > DAIDS grade 3 Total triglycerides (total cholesterol no restriction)
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 XRNevirapine XR | Drug | NVP IR |
| Nevirapine XRNevirapine extended release | Drug | NVP XR |
| Nevirapine IRNevirapine Immediate Release | Drug | NVP IR |
Primary outcome
Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Time frame: week 24
Primary endpoint was the number of patients with a sustained virologic response through week 24
42 secondary outcomes
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Time frame: week 2
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Time frame: week 4
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Time frame: week 8
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Time frame: week 12
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Time frame: week 24
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Time frame: week 0 to 24
Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population
Time frame: week 0
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 2
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 4
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 8
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 12
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 24
Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 24
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Time frame: week 48
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Time frame: week 60
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Time frame: week 72
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Time frame: week 84
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Time frame: week 96
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Time frame: week 108
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Time frame: week 120
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Time frame: week 132
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Time frame: week 144
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Time frame: last available visit, up to 144 weeks
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 48
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 60
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 72
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 84
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 96
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 108
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 120
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 132
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 144
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population
Time frame: baseline, last available visit (up to 144 weeks)
Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144
Time frame: week 144
Change From Baseline in VL (HIV-1 Viral Load) at Each Visit
Time frame: week 48, 60, 72, 84, 96, 108, 120, 132, 144, last available visit
Changes in Safety Parameters Related to Treatment
Time frame: until week 144
Occurence of Rashes
Time frame: 144 weeks
Occurence of Hepatic Events
Time frame: 144 weeks
New AIDS or AIDS-related Progression Event or Death
Time frame: 144 weeks
Time to Loss of Virologic Response
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
39 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nevirapine XR and Nevirapine IR in people with HIV Infections, run by Boehringer Ingelheim at 39 sites in 4 countries.
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 11 inclusion and 15 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 10 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Germany, United States, France, United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 24 Feb 2012). 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?
Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population (time frame: week 24). 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 10 Nov 2014.