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Investigational Medications

Name & maker:
BMS-663068
Bristol-Myers Squibb

What it does:
BMS-663068 is the first investigational antiretroviral to prevent initial viral attachment to the host CD4+ T cell and entry into the host immune cell by binding directly to the virus. Findings from week 24 of a Phase IIb trial are promising: specifically, the virus was undetectable in 69 percent to 80 percent of patients, with no serious complications.

 

Name & maker:
Atazanvir Sulfate with Cobicistat
Bristol-Myers Squibb

What it does:
In April Bristol-Myers Squibb submitted an application U.S. Food and Drug Administration for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz, and cobicistat, an investigational boosting agent that can increase the level of certain HIV-1 medicines in the blood and make them more effective. If approved, atazanavir sulfate and cobicistat could offer patients living with HIV-1 (the most common strain of HIV) a single tablet that eliminates the need to take a boosting agent in a separate pill.

 

Name & maker:
Tenofovir-UC781
Gilead Sciences

What it does:
One form of tenofovir is marketed as an oral HIV medication under the  brand name Viread, but it has also been studied as a component of a microbicide gel for a vaginal use. While some gel trials have produced disappointing results, scientists are studying whether tenofovir’s performance can be improved by combining it with the nonnucleoside reverse transcriptase inhibitor UC781 in a vaginal gel and potentially a film. Gilead Sciences has granted a license to nonprofits Conrad and the International Partnership for Microbicides to create a gel that could be used by women in developing countries to prevent HIV transmission during sex. Clinical trials in South Africa are ongoing. An intravaginal ring that would dispense tenofovir is also under development.



Name & maker:
Elvitegravir
Gilead Sciences

What it does:
A type of medicine that blocks integrase, a protein that HIV needs to insert its viral genetic material into the genetic material of an infected cell, elvitegravir is taken orally to fight HIV, in combination with other antiretroviral medicines. Elvitegravir is a component of the Stribild combination pill. Elvitegravir was approved for use as a stand-alone under the brand name Viketa in the European Union, Canada, and Australia, but an application for U.S. use is still under review by the FDA.


Name & maker:
Cobicistat, (GS-9350)
Gilead Sciences

What it does:
Cobicistat is a pharmaco-enhancer or “boosting agent” that raises the blood levels of other drugs that are broken down by the same protein. Cobicistat itself does not have any antiviral activity. Like elvitegravir, it is a component of Stribild. It has been approved as a stand-alone drug under the brand name Tybost in the European Union, Canada, and Australia, but an application for U.S. use is still under review by the FDA.


Name & maker:
572_trii
ViiV

What it does:
A single-pill, complete regimen that contains the integrase inhibitor dolutegravir and Epzicom, an already-approved drug that prevents HIV from altering the genetic material of healthy CD4 cells. Dolutegravir is an integrase inhibitor that targets HIV integrase, an enzyme required for the integration of viral DNA into the host cell genome, in an effort to prevent HIV from replicating. Dolutegravir is marketed under the brand name Tivicay and received FDA approval as a stand-alone drug in August 2013. 572_trii is currently in Phase III clinical trials.


Name & maker:
’744 LAP
ViiV

What it does:
S/GSK1265744, or simply ’744 LAP, is an integrase inhibitor that is considered ViiV’s follow-up to dolutegravir. The drug is currently in Phase II studies to evaluate the long-term safety and tolerability of oral and injectable forms.

 

Name & maker:
Tenofovir alafenamide
Gilead Sciences

What it does:
Tenofovir disoproxil fumarate, a nucleoside reverse transcriptase inhibitor, is already available as an anti-HIV pill under the brand name Viread and as a component of several combination drugs, including Stribild. Gilead is currently conducting clinical trials of a variant, tenofovir alafenamide or TAF (formerly GS-7340); TAF may be able to have a greater antiviral effect than Viread at a dose that is 10 times lower and is better distributed into lymphoid tissues, potentially improving the tolerability of HIV therapy. In a Phase II study, the TAF-based single tablet regimen suppressed the virus as well as Stribild while being gentler on kidneys and bones. Several Phase III studies regarding its efficacy, including a single-tablet regimen of TAF combined with elvitegravir, cobicistat, and emtricitabine, are ongoing, with estimated completion dates in 2015 and 2016.

 

Name & maker:
Ibalizumab
TaiMed

What it does:
A CXCR4 inhibitor, which works by blocking HIV’s entry into cells, ibalizumab (formerly known as TMB-355), is injected intravenously to treat HIV. Various doses, based on body weight, have been studied. A form of the drug to be injected subcutaneously, which would allow patients to inject it under the skin without assistance, is also being evaluated.

 

Name & maker:
Apricitabine
Avexa Ltd.

What it does:
Apricitabine is a new nucleoside reverse transcriptase inhibitor that may work for people with HIV strains that are resistant to other NRTIs. Other names for it include ATC, AVX754, and SPD754.

 

Name & maker:
Elvucitabine
Achillion Pharmaceuticals

What it does:
Another NRTI, elvucitabine (or ACH-126443) is similar to the FDA-approved anti-HIV drug lamivudine (Epivir). Elvucitabine may be effective in treating individuals infected with HIV strains resistant to lamivudine and may delay the emergence of resistance and prolong the effectiveness of therapy. Phase II clinical trials have been completed.

 

Name & maker:
KP-1461
Koronis Pharmaceuticals

What it does:
KP-1461 is an oral form of KP-1212, a compound shown to be effective in cell culture against HIV. It is also effective against viruses with mutations conferring resistance to many of the drugs currently approved for HIV treatment. It is being refined for further study.

 

Name & maker:
VivaGel
Starpharma

What it does:
VivaGel is a vaginal microbicide gel that is being studied for the prevention of HIV and other STIs, including herpes simplex virus-2. In tests, it has been given either once or twice daily, for up to two weeks. Its active ingredient is SPL7013, an HIV inhibitor.

 

Name & maker:
Pro 140
CytoDyn

What it does:
PRO 140 is an antibody, not a drug, designed to block HIV from entering a cell. It accomplishes this by binding to a molecule called CCR5, a normal cell protein that HIV attaches to after contact with the primary receptor for the virus. PRO 140 has no apparent issues with toxicity, and could serve a role as PrEP or PEP in treating high-risk negative individuals.


Name & maker:
Ampligen
Hemispherx Biopharma

What it does:
Ampligen is an RNA drug product that is administered intravenously. It’s in human clinical development for various therapeutically oriented studies, including treatment for HIV, renal cell carcinoma, and malignant melanoma.

 

Name & maker:
Mucocept
Osel Inc.

What it does:
MucoCept, a third-generation engineered probiotic product, is in pre-clinical development and nearing an Investigational New Drug submission as a novel microbicide for the prevention of HIV infection in women.

 

Name & maker:
AGS-004
Argos Therapeudics

What it does:
Argos Therapeutics employs a trademarked technology called Arcelis, an immunotherapy that is tailored to the immune response of individual patients. Its most promising candidate for HIV treatment with this technology, AGS-004, currently in Phase IIb of testing, takes small plasma samples from patients in order to generate a response by the patient’s immune system to the virus. Results from Phase IIa were promising, showing a significant viral load reduction and delay in viral rebound during a 12-week interruption of antiretroviral treatment, compared to those before treatment.

 

Name & maker:
Cal-1
Calimmune

What it does:
In 2008 doctors announced that an American treated in Berlin had been effectively cured of HIV after undergoing a transplant of bone marrow stem cells as treatment for leukemia the previous year. Since then, scientists have attempted to replicate this result through the development of a blood stem cell therapy that would block the expression of the CCR5 protein, which the virus uses to enter T cells. Calimmune has developed a gene medicine called Cal-1, which would modify a person’s T cells and blood stem cells to block CCR5 so that HIV could not enter. The strategy is current in Phase I and II human trials, with results expected in 2015.

 

Name & maker:
Dapivirine
International Partnership for Microbiocides

What it does:
As a nonnucleoside reverse transcriptase inhibitor, or NNRTI, dapivirine prevents HIV from replicating its genetic material after the virus enters a healthy cell. IPM is evaluating two methods for administration of dapirivine by women to prevent sexual transmission of HIV: a vaginal gel for daily use and a vaginal ring for monthly administration. They have been through Phase I and II trials, and two Phase III studies of the dapirivine ring are going on in Africa, from which results are expected in 2016.

 

Name & maker:
DermaVir
Genetic Immunity

What it does:
DermaVir is a post-infection vaccine that helps make HIV more visible to the body’s immune system, thereby enabling it to attack the virus. It is administered by applying it under a patch to skin that has been deliberately irritated. DermaVir releases a small amount of the virus’s DNA into the skin, where it is picked up by dendritic cells and then transported the lymph nodes, where T cells are generated, and elevates the ability of healthy T cells to recognize and destroy the virus.

 

Name & maker:
HIV Vaccine
GeoVax Labs

What it does:
Utilizing DNA and viral vector technologies, GeoVax Lab is developing a vaccine to prevent HIV infection. This vaccine, which recently completed Phase II safety trials through the U.S. government-sponsored HIV Vaccine Trials Network, is also being tested in a Phase I trial as a treatment for HIV-positive patients, which may reduce the need for treatment with drugs.

 

Name & maker:
Doravirine
Merck

What it does:
Doravirine, a nonnucleoside reverse transcriptase inhibitor, showed promise in suppressing HIV with fewer side effects than some other medications in a Phase II trial, the results of which were presented at a conference in March. Patients took the drug in combination with Truvada (itself a combo of emtricitabine and tenofovir). Merck plans to start a Phase III trial in the second half of 2014.

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