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T-20 Clinical Trial for treatment naive
Jan 30, 2007

Hi, thanks for all your information regarding Fusion Inhibitors.

I've recently been diagnosed with HIV (12/11/06). My numbers are right at "treatment" levels (CD4 336/19%, VL 286000). I have my second set of numbers run next month to establish my baselines. If the numbers are around the same, then my Doctor and I will talk about starting treatment.

The trial I'm considering is: ClinicalTrials.gov identifier NCT00051831: "Effect of an Enfuvirtide-Based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults"

This trial basically uses a standard oral cocktail, along with twice daily T20 injections in an attempt to eradicate HIV infection in the various long lived reservoirs.

For me, while the possibility of this kind of aggressive treatment as a "cure" is intriguing, I'm just hopeful that it can really make a huge initial impact to reduce my viral load significantly and possibly with long term affect; as even with a CD4 count of 336, I'm still seeing various "symptoms" having to do with such a high VL in my lymph tissues such as stomach upset, swelling, soreness, chronic toncelitus, etc.

I understand that we're talking about a HUGE treatment impact of a twice daily injections. Luckily(?), as a child I had sever allergies and took injection based therapy for 13 years. I'll also be asking if they are using actual "shots" vs the "hypospray like" technology.

I know that T20/Fuzeon treatments are often "saved" as a last line of defense for various treatment failures. So my question is, by "starting" with a Fuzeon treatment regime that has a finite "course" of 96 weeks, am I putting myself at an extreme risk of not having this treatment option available if I were to face treatment failure down the road?

I'll be discussing this with my Dr (who is also at Duke where the trial is being ran), but I just wanted your initial reactions as well so I have more than just one opinion.

Thanks so much for any advice that you can provide.

Response from Ms. Salisbury

Hi, I am quite interested in this study you speak of. I would love to get more information. What a great study design! Fuzeon has the ability to prevent viral entry and it would be a great drug regimen when given with other HIV drugs in naive patients (someone who has never been on HIV drugs). It is very important to drive the virus down to non-detectable as low as the lab value goes (usually less than 50). If viral load is elimated to that degree the virus would have difficulty becoming resistant to the Fuzeon. Taking HIV meds without interruption and close monitoring of viral loads is important.

Any HIV medication can be lost to poor adherence and ongoing viral replication. I am very optimistic that there are new classes of HIV meds coming such as the Entry inhibitors, integrase inhibitors and maturation inhibitors. Some are close to approval. HIV treatment has many options these days. Good luck with your new study/treatment. Carol



  
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