This trial is no longer enrolling. This may mean the trial is fully enrolled, or that enrolment in the trial has been halted or suspended. You cannot enrol in this trial.
About this trial
We don't know why antiretroviralA medication or other substance which is active against retroviruses such as HIV. treatment can suppress some people's viral loadA measurement of the quantity of HIV RNA in the blood. Viral load blood test results are expressed as the number of copies (of HIV) per milliliter of blood plasma. but not give them a good T cell count.
This study will test two theories:
The first is that even a low level of viral activity prevents some people from rebuilding their immune system and therefore they need a stronger treatment regimen, in this case one boosted with the new integrase inhibitor - raltegravir.
The second theory is that HIV attacks the gut wall causing infections which the body has to constantly fight. So, this trial adds bovine colostrum to the mix - a compound which helps heal the gut and has been used in the past to treat chronic diarrhea in HIV.
See: Immuron's BioGard HIV Antibody Into A U.S. Clinical TrialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. http://www.medicalnewstoday.com/articles/135621.php
Background information
Raltegravir is the first drug in the new class of antiretroviralsA medication or other substance which is active against retroviruses such as HIV. called integrase inhibitors whose function it is to block integration of HIV DNA into the cell nucleus.
To infect a human host cell, HIV undertakes a complex enterprise. It must attach to the cell, fuse with it, and finally ‘reprogram’ the human cell with its own genetic material, producing new copies of itself and going on to infect more cells with new viral particles.
Theoretically, we can target this life cycle and attempt to interfere with HIV replication at any of a number of different points, often by inhibiting the enzymes which are crucial to a particular stage of the virusA small infective organism which is incapable of reproducing outside a host cell.’s development.
Nucleoside/nucleotide reverse transcriptase inhibitors and non-nucleoside reverse transcriptase inhibitors (NtRTIs and NNRTIs) work by targeting an enzyme called reverse transcriptase while protease inhibitors target a different enzyme called protease. Integrase inhibitors (e.g. raltegravir) work by inhibiting another enzyme, integrase, which HIV uses to integrate its genetic material with the host cell. Without this enzyme, HIV can’t reprogram the human host cell’s DNA, and its life cycle is cut short.
Integrase inhibitors have long been a kind of ‘holy grail’ for HIV drug development, and their arrival represents an important development. Used in combination with drugs from the other classes, this approach provides a fresh front for attacking HIV.
Like all other anti-HIV drugs, raltegravir is taken in combination with an optimised background therapy - a combination of HIV drugs chosen because it is the most likely to control HIV in the participants being studied.
Bovine colostrum is a 'pre-milk' produced by cows for their young and is up to ten times more potent than the colostrum produced by humans. Bovine colostrum is an incredible source of immunoglobins, immuno-enhancing molecules, transfer factors and growth-stimulating factors. IgG is the most abundant immunoglobin found in bovine colostrum and assists in the body's immune response to infection. Found within the blood, lymphatic system and mucous membranes, IgG may help strengthen and modulate the immune system.
| Official title: | A randomized, double-blind, placebo controlled multi-centre study to measure the effect on CD4+ outcomes of combination antiretroviral therapy (cART) intensification with or without passive immunotherapy to reduce immune activation in HIV infected individuals with persistent CD4+ T-cell count of less than 350 cells despite prolonged HIV plasma viraemia of less than 50 copies for at least 12 months on combination antiretroviral therapy. |
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| What is this trial studying? | Treatment strategy – raltegravir, bovine colostrum |
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| How many participants will this trial enrol? | 75 The exact number of participants may be lower or slightly higher than this. Some trials also have specific quotas for participants from each state, city or clinic. |
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| How long is this trial planned to go for? | Participants in this trial will be asked to follow the treatment strategy for 48 weeks. Following the conclusion of the trial, participants will be followed up for a further 48 weeks. |
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| Can I access this treatment other than by enrolling in this trial? | Raltegravir is listed on PBS[Pharmaceutical Benefits Scheme] The federal government program which subsidises medication costs in Australia. Anti-HIV drugs are part of a special part of the PBS called Section 100 (S100) which is used for expensive, highly specialised drugs. from 1 July 2008. Bovine colostrum is widely available as a health supplement and comes in various forms and consistencies.
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Who can enrol in this trial?
You may be eligible to participate in this trial if you meet the following criteria:
- At least 18 years old
- Currently taking HIV treatments
- CD4 count below 350 cells/mm3
- Viral load below 50 copies/ml
- Been on antiretrovirals for at least 12 months and on a stable regimen for the last six months
- Had undetectable viral load results for the last nine months (allowing for one isolated blip) and stable CD4 count of less than 350 for the last six months
You
will not be eligible to participate in this trial if you meet any of the following criteria:
- Not already on an integrase inhibitor
- Not planning to change therapy
This is a summary of key inclusion and exclusion criteria for this trial. There may be other criteria which may exclude some people from participation in this trial. Some laboratory tests may also be required. Consult your doctor, or view the trial protocol or informed consent documentation to see the full range of exclusion and inclusion criteria.
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