<<Has anyone seen a trial using Viracept and Crixivan, along with whatever else?>>
<<What is your source of information that Viracept has been tested in combination with <<Sustiva? Who would sponsor such a trial? It's against DuPont-Merck's interest.>>
FYI: Some trials in progress: include the NIH sponsored -
AIDS Clinical Trial Groups (ACTG) and more.
1. ACTG 359
Fortovase, ritonavir (rit), nelfinavir (nlf), delavirdine (dlv), adefovir (adf)
Aim of trial to find the best second treatment for viral failure on Crixivan
All groups will take Fortovase: Additional treatments will be
rit/dlv; rit/adf: rit/dlv; nlf/dlv/ nlf/adf: nlf/dlv.
Study 24-48 weeks.
2. ACTG 364 - Nefinavir (Viracept) DMP-266, AZT, 3TC, ddI, ddC, d4T
Nelfinavir with or without DMP-266, in combination with or without one or two nucleosides. This trial is a rollover from ACTG 302/303. Study-48 weeks.
3. ACTG 372 -Indinavir, abacavir (1592), AZT, d4t, 3TC, DMP266, adefovir, nelfinavir
For patients already on IDV/AZT/3TC. Divided according to their viral load
Patients with viral load under 500 copies, abacavir will be added
If viral load exceeds 500 copies, nelfinavir will be added to abacavir/indinavir/AZT/3TC.
4. DMP 024
Combination of DMP-266 and Nelfinavir. Two groups of DMP-266 + NLF,
One na‹ve to all NNRTI, one not.
5. FDA 246H. Study combination of indinavir (Crixivan) and nelfinavir(Viracept), in combination and separately, at different doses of nelfinavir. After two weeks, all participants take both study drugs for the rest of the 24. Protease inhibitor na‹ve patients. Open label. Study: 24 weeks.
6. CPCRA 042 (NIH sponsored Community Programs for Clinical Research on AIDS)
Compares Nelfinavir (Viracept) to Ritonavir (Norvir)
Compare: Viracept +AZT, ddI, ddC, d4T, 3Tc to
Norvir + AZT, ddI, ddC, d4T, 3Tc
Patients can switch pi's in event of disease progression or side effects.
Open label. Study is 18 months.
7. NR 15521A Saquinavir sgc (Fortovase), Nelfinavir, d4T, ritonavir
3 groups: Open label
1. Saq TID with 2 anti-HIV drugs new to patient
2. Saq BID with Nelfinavir and d4T or a new anti-HIV drug
3. Saq at lower dose BID, with ritonavir and d4t or new anti-HIV drug
8. GS417. Study adefovir dipivoxil in combination with other drugs: adefovir nelfinavir, saquinavir sgc, AZT, 3TC, d4T. Three groups:
1. The first group will take adefovir, nelfinavir and saquinavir.
2. The second group will take adefovir, nelfinavir and either AZT, d4T or 3TC depending on what was taken in the past.
3. The third group will take adefovir, saquinavir, and either AZT, d4T or 3TC depending on what was taken in the past.
All participants will also take L-carnitine. Require at least one month of prior treatment with reverse transcriptase inhibitors. Must be protease inhibitor and adefovir dipivoxil na‹ve. Total time on study is 48 weeks. Open label, except for dose.
9. M33310073. Drug: delavirdine, nelfinavir, ddI, d4T. Combination treatments for HIV infection. The study drugs are delavirdine, nelfinavir, ddI, and d4T. 4 groups:
1.The first group will be treated with delavirdine, nelfinavir and ddI.
2. The second group will be treated with delavirdine, nelfinavir, and d4T.
3. The third group will be treated with delavirdine, ddI, d4T, and nelfinavir.
4. The fourth group will be treated with ddI, delavirdine, and d4t.
Open label. (added 10/21/97)
More details of above studies available at: 204.179.124.69
Some other ongoing clinical trial combinations are: NFV/SQVsgc and 141/NFV
Details at: healthcg.com
And HIV Infection: Nelfinavir, Hydroxyurea, d4T, ddI
hivinsite.ucsf.edu
The Options Project, at UCSF, has a treatment program for persons infected with HIV for less than six months, and has treated 37 persons with early HIV infection who are all doing well, with no drug treatment failures reported. Early treatment may be important because drugs may be more successful when HIV may be more 'vulnerable', when it hasn't spread throughout the body and hasn't had a chance to mutate, James Kahn said. The individual's immune system is also stronger early in infection and therapy may be more effective then, he said.
Acute infection symptoms occur within a week to three months after exposure, and common symptoms include fever, rash, sore throat, muscle aches, and severe fatigue. Patients are included with early HIV Infection who have newly seroconverted,
i.e. convert from HIV negative to HIV positive. chanane.ucsf.edu
Two of these clinical trials are:
HIV Infection in Newly Seroconverted: VIRACEPT, AZT, 3TC
hivinsite.ucsf.edu
HIV Infection in Newly Seroconverted: d4T, ddI, Nelfinavir, Hydroxyurea
hivinsite.ucsf.edu
There are many other ongoing clinical trials, not all have been mentioned. New data is expected to be presented at Annual Retrovirus meeting in February. Data that will support market demand for Viracept (total of 20 abstracts to be presented-from PW) including more on the Viracept BID regimen. Also, according to Dr. Stephen Deeks, there will be data presented there "that indinavir or indinavir plus a non-nuke works very well patients who have failed nelfinavir." This combination is now listed in the revised Guidelines of Possible Regimens For Patients Who Have Failed Antiretroviral Therapy: A Work in Progress*# Revised.Table XIV
aids.miningco.com
thebody.com re: Adefovir
thebody.com re: problems with 1592.
|
