text:
HIV-1 Infection Study of Once a Day Versus Twice a Day Protease Inhibitor in Antiretroviral Treatment Naive Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
|ClinicalTrials.gov Identifier: NCT00450580
Recruitment Status : Completed
First Posted : March 22, 2007
Results First Posted : September 2, 2009
Last Update Posted : June 7, 2012
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
|Condition or disease
|Infection, Human Immunodeficiency Virus I HIV-1 Infection
|Drug: fosamprenavir/ritonavir
|Phase 3
|Study Type :
|Interventional (Clinical Trial)
|Actual Enrollment :
|212 participants
|Intervention Model:
|Parallel Assignment
|None (Open Label)
|Primary Purpose:
|Official Title:
|Study of Once-Daily Versus Twice-Daily Fosamprenavir Plus Ritonavir, Administered With Abacavir/Lamivudine Once-Daily in Antiretroviral-Naive HIV-1 Infected Adult Subjects.
|Study Start Date :
|March 2007
|Actual Primary Completion Date :
|August 2008
|Actual Study Completion Date :
|August 2008
Experimental: Arm A
Fosamprenavir/ritonavir 1400mg/100mg QD + ABC/3TC FDC 600/300mg QD
Drug: fosamprenavir/ritonavir
Fosamprenavir (FPV, TELZIR) is currently licensed in Europe for twice daily (BID) dosing in combination with ritonavir (RTV, Norvir) as a boosting agent
Active Comparator: Arm B
Fosamprenavir/ritonavir 700mg/100mg BID + ABC/3TC FDC 600/300mg QD
Drug: fosamprenavir/ritonavir
Fosamprenavir (FPV, TELZIR) is currently licensed in Europe for twice daily (BID) dosing in combination with ritonavir (RTV, Norvir) as a boosting agent
- Percentage of Participants With HIV-1 RNA <400 and >=400 Copies/mL Over 48 Weeks [ Time Frame: Week 48 ]A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at week 48. The percentage of participants with HIV-1 RNA <400 copies/mL at Week 48 was determined by the Time to Loss Of Virologic Response (TLOVR) algorithm.
- Percentage of Participants With HIV-1 RNA <50 and >=50 Copies/mL by Visit Over 48 Weeks [ Time Frame: Week 48 ]A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at week 48. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was determined by the TLOVR algorithm
- Number of Participants With HIV-1 RNA <400 Copies/mL (Primary Endpoint) at Week 48 Categorised by Baseline Viral Load, TLOVR Analysis [ Time Frame: Week 48 ]The number of participants with HIV-1 RNA <400 copies/mL at Week 48 was determined (by analysis of blood draw) and categorised by baseline viral load (BVL).
- Number of Participants With HIV-1 RNA <400 Copies/mL (Primary Endpoint) at Week 48 Categorised by Baseline CD4+ Count, TLOVR Analysis [ Time Frame: Week 48 ]The number of participants with HIV-1 RNA <400 copies/mL at week 48 was determined (by analysis of blood draw) and categorised by baseline CD4+ count.
- Change From Baseline in Non-HDL Cholesterol at Week 48 [ Time Frame: Week 48 ]Blood samples were drawn to determine the non-HDL cholesterol levels at Week 48. The mean absolute change in non-HDL cholesterol was defined as the Week 48 levels minus levels at baseline.
- Number of Protocol-defined Virological Failures With Genotypic and Phenotypic Resistance Changes [ Time Frame: Time to virologic failure; Week 4 up to Week 48 ]A blood sample was drawn at the time of confirmation of virological failure, and mutations present in the virus were identified and compared to those found in the blood sample at baseline. New mutations were tabulated by drug class. RT, reverse transcriptase. Virological failure could occur anytime from Week 4 to Week 48.
- Steady-state Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 4, 12, and 24 [ Time Frame: Weeks 4, 12, and 24 ]Blood samples were drawn at Weeks 4, 12, and 24 to determine plasma concentrations (Ctau) of APV and RTV
- Study Endpoints for a Subset of Subjects Receiving Study Drug Beyond 48 Weeks [ Time Frame: Up to 60 weeks ]Adaptive two-stage design study up to 48 weeks. N=200, expanding to 728 if continuation criteria were achieved based on a 24-week interim analysis. The initial 200 participants would continue until the last subject of the expanded cohort reached 48 weeks and would constitute the subset. As continuation criteria were not achieved, the study did not proceed to the second stage, and full analysis was performed on the initial 200 participants only.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:
|18 Years and older (Adult, Older Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion Criteria:
- Subject is ≥18 years of age.
- Subject is antiretroviral-naïve (defined as having ≤14 days of prior therapy with any antiretroviral agent).
- Subject has plasma HIV-1 RNA ≥1,000 copies/mL at screening.
- Subject is willing and able to understand and provide written informed consent prior to participation in this study.
A female is eligible to enter and participate in the study if she is of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or,
Child-bearing potential, has a negative pregnancy test (serum b-HCG) at screen and agrees to one of the following methods of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the approved product label and the instructions of a physician):
- Complete abstinence from intercourse from 2 weeks prior to administration of the investigational products, throughout the study, and for at least 2 weeks after discontinuation of all study medications
- Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide). Hormonal contraception will not be permitted in this study
- Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year.
- Sterilization (female subject or male partner of female subject). All subjects participating in the study should be counselled on the practice of safer sex.
- Prior to randomization, subjects entering Stage 2 must have been screened and be negative for the HLA-B*5701 allele. Test may be performed by local laboratory and results must be available for source document verification according to local practices.
Exclusion Criteria:
- Subject is in the initial acute phase of a CDC Clinical Category C infection at Baseline. Subjects may be enrolled provided they are receiving treatment for such infections and are clinically improving at the Baseline visit.
- Subject is enrolled in one or more investigational drug protocols, which may impact HIV RNA suppression.
- Subject is, in the opinion of the Investigator, unable to complete the study dosing period and protocol evaluations and assessments.
- Subject is either pregnant or breastfeeding.
- Subject suffers from any serious medical condition (such as pancreatitis, diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction) which in the opinion of the Investigator would compromise the safety of the subject.
- Subject has a pre-existing mental, physical, or substance abuse disorder which, in the opinion of the Investigator, may interfere with the subject's ability to comply with the dosing schedule and protocol evaluations and assessments.
- Subject has a history of inflammatory bowel disease or intestinal malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction, which, in the opinion of the Investigator, may interfere with drug absorption or render the subject unable to take oral medication.
- Subject has any acute laboratory abnormality at screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound. If subjects are found to have an acute Grade 4 laboratory abnormality at screening, this test may be repeated once within the 45-day screening window. Any verified Grade 4 laboratory abnormality would exclude a subject from study participation.
- Subject has an estimated creatinine clearance < 50 mL/min via the Cockcroft-Gault method [Cockcroft, 1976]. This test may be repeated once within the 45-day screening window.
NOTE: Creatinine clearance should be estimated using the following formula:
For serum creatinine concentration in mg/dL:
For serum creatinine concentration in µmol/L:
- Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN) or hepatic impairment as determined by Child-Pugh Score ≥ 5.
- Subject is receiving, or has received within 90 days prior to screen, any lipid lowering agent, including drugs from the following classes: HMG-CoA reductase inhibitors (statins), niacin, fibrates, bile acid sequestrants, and/or fish oil supplements. Subjects anticipated to require initiation of therapy with these agents within 12 weeks of Baseline are not eligible to participate.
- Subject has received treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to Screening, or has an anticipated need for these agents within the study period.
- Subject has received treatment with an HIV-1 immunotherapeutic vaccine or any agents with documented activity against HIV-1 in vitro within 28 days prior Screening, or an anticipated need during the study.
Subjects who require treatment with any of the following medications within 28 days of commencement of investigational product, or an anticipated need during the study:
- Amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergonovine, ergotamine, flecainide, halofantrine, lidocaine, lovastatin, methylergonovine, midazolam, pimozide, propafenone, quinidine, simvastatin, terfenadine, triazolam.
- Carbamazepine, dexamethasone, phenobarbital, phenytoin, primidone, rifampin, St Johns Wort (Hypericum perforatum), troglitazone.
- Systemic interleukins or interferons.
- Subject has a history of allergy to any of the investigational products or any excipients therein.
- Subject has evidence of genotypic (as defined by the current ANRS AC-11 algorithm) resistance at screening or prior documented evidence of genotypic and/or phenotypic (above threshold for reduced susceptibility) resistance to amprenavir/ritonavir, abacavir or lamivudine.
Subjects recruited at sites in France will be excluded if:
- The subject is not affiliated with or a beneficiary of a social security.
- The subject has previously participated in an experimental drug and/or vaccine trial(s) within 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine - whichever is longer, prior to screening for the study.
- The subject will participate simultaneously in another clinical study. Notwithstanding these minimum inclusion and exclusion criteria, investigators are urged to follow country specific guidelines where they exist when making decisions about subjects who are eligible for study participation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450580
|Study Director:
|GSK Clinical Trials
|ViiV Healthcare
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:
|ViiV Healthcare
|ClinicalTrials.gov Identifier:
|Other Study ID Numbers:
|First Posted:
|March 22, 2007 Key Record Dates
|Results First Posted:
|September 2, 2009
|Last Update Posted:
|June 7, 2012
|Last Verified:
|April 2012
protease inhibitor,
non-HDL cholesterol
Communicable Diseases
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors


text:
Professional Community for Car Dealers, Marketing, Advertising and Sales Leaders
The automation of Twitter for businesses continues to become the norm.
As micro-blogging, interaction, and expression get replaced by RSS feeds, Facebook feeds, and post scheduling that is all dominated by links, links, and more links, the power of Twitter is being replaced by the easy alternatives to actually, well, using the service.
This is a huge mistake for most. There are some who are simply overwhelmed by social media and internet marketing in general and anything that they can check off their list with minimal or zero effort is a good thing. For those who actually want to find success on Twitter, it's not going to work with zero effort. Thankfully, Twitter is a platform that can work very well with minimal effort. There has to be some, just not a ton.
When I first started using Twitter over five years ago, the site was loaded with communication. Links were in fewer than 20% of the Tweets in my feeds. It was mostly about, "look at what I'm doing here" or "I really like pickles". Now, links dominate Tweets. For news sources and other publications, this is fine. For super-active accounts that talk to people regularly, this is fine. For businesses who are not super-popular on social media, links should be used sparingly.
Again, it comes down to time. If you simply don't have the time to come up with 3 or 4 good, solid unlinked Tweets, interactions with everyone who reaches out to you, and proactive interactions with new people the way a proper Twitter strategy should look, then getting something out there on a regular basis is better than going completely stagnant. The effectiveness of the "bail out" strategy is minimal, but if it's all that you can afford from a time perspective, so be it.
It's it's at all possible to tone down the links and get truly engaging with your posts, you'll get much more out of the service for your business.
It would have been hard to imagine in the days when I was first getting started on Twitter that there would be a need to give this advice, but that need is here. Twitter is first and foremost a communication tool. Most businesses are using it strictly for broadcasting. The paradox that many fail to understand is that if you talk about yourself less and talk about others more, your messages about yourself will reach a greater number of people. In many ways, it's about earning the right to broadcast.
Those who use Twitter regularly can smell a feed-driven Twitter account in seconds. They can tell when an account is strictly being used to broadcast and when it's truly being used for communication. When someone is strictly broadcasting, they better be a publication like Mashable or a celebrity like Oprah Winfrey or the message simply won't be heard.
Here are some quick ways to establish that you're communicating on Twitter rather than broadcasting:
Once you've established that you communicate properly through Twitter, you'll have room to post occasional self-serving links. If all you post is links, your message will get lost in the mix.
Twitter has a great filter feature for mobile images. Use it. Before we recommended Instagram but that didn't work out so well, so Tweeting images directly through the Twitter mobile app works great.
If you use Buffer or any of the other posting tools that upload images directly to Twitter (Hootsuite doesn't do this, FYI), scheduling images through a PC is another way to get your feed flowing with engaging content. It's not as good as mobile uploads as people love to see real pictures taken by real people associated with the business, but it's definitely better than nothing.
Text posts are great as well. They can be sayings, quotes, opinions, or anything that has nothing other than possibly hashtags linking out from the Tweet. This is particularly useful when posting about local area events and asking questions. One note: if you do ask questions designed to get a response from your followers, be sure that you're available to respond to their answers. Don't drop a question in the queue and walk away. Again, timeliness is important, even for a business Twitter account.
* * *
Twitter is the one component of social media strategies that has been botched by most over the years. It's hard to get real followers. It's harder to get real engagement.
It can, however, prove to be extremely useful if you put the effort into it. Again, and I cannot stress this enough, the effort that's required to take a Twitter account from decent to great really isn't that much. It's for this reason that if you have a little extra time every day, Twitter is a good investment of it.
Views: 196
Great post JD. Solid steps and specific recommendations that make sense.
And they should stop piling on the OEM content. Let the OEM's take care of their own content. Connect with your user-base through informative, original and engaging content and learn as you go along. It's not an exact science, but you can measure what's working for your dealership and demographic. Although I believe in best practices, every dealership is different.
Can we depend on Twitter, and the other services they are eating up, to provide us with an experience fit for us? Or do we want to toggle the algorithms off, and curate the content on our own? It's a double-edged sword, really: If we choose to curate all of this information on our own, we're overwhelmed; if we choose to allow Twitter and its robot army (e.g., algorithm-based services) to do so for us, it may not provide us with what we need.
I've found a nice little application for video sharing if anyone is interested and it's dofollow with a PR of 6 @ http://www.twitvid.com. Push up your inventory videos or TV commercials.
Moral of the story here for me is... Make it more a two way boulevard and less a one way highway... oh and be human...Great insights and post. Thanks as always!
+1! ;)
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