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Pearls of Wisdom from the 11th CROI -
February 2004
1. High-concentration Capsaicin Patch for the Treatment of Painful
HIV (#490)
- The application of a high dose casaicin patch to the area
of the body affected with neuropathy symptoms resulted in an average
40% decline in neuropathy pain during the twelve week study period .
A single dose application of the patch is a 2-3 hour procedure.
2. Efficacy and Safety of Atazanavir
with Ritonavir or Saquinavir vs Lopinavir/Ritonavir in Patients Who
Have Experienced Virologic Failure on Multiple HAART Regimens: 48-Week
Results (#547)
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Atazanavir (Reyataz) boosted with Ritonovir was of similar
efficacy to Kaletra in patients who had multiple antiviral medication
failures in the past.
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Atazanavir (Reyataz) boosted
with Ritonovir had a more favorable effect on lipids (cholesterol
and triglycerides) than Kaletra. Lipid
levels generally decreased in the Reyataz regimens and increased or
remained stable in the Kaletra-containing regimens.
3. Nevirapine Plasma Concentrations Are Still Detectable after
More than 2 Weeks in the Majority of Women Receiving Single-dose NVP:
Implications for Intervention Studies (#891)
- The majority of women who received a single NVP dose of 200 mg still
had detectable plasma concentrations of NVP after more than 2 weeks.
Seven subjects still had NVP detectable on Day #21, the last day of
sampling for this study. These results suggest that it would be wise to
discontinue NVP up to two weeks prior to stopping other medications to
avoid the development of resistance.
4. Low-dose Maintenance Therapy with Recombinant Human Growth
Hormone Sustains Effects of Previous r-hGH Treatment in HIV+ Patients
with Excess Center Fat: Treatment Results
at 60 Weeks (#80)
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This study sought to evaluate the evaluated the efficacy and safety
of r-hGH (Serostim) maintenance therapy, 1 or 2 mg daily, to sustain
reductions of trunk fat and cholesterol concentrations induced by
prior treatment with higher-dose r-hGH. In the antecedent
STARS trial, r-hGH doses of 4 mg/day for 12 weeks significantly reduced
trunk fat, visceral adipose tissue, total cholesterol, and non- HDL cholesterol,
relative to placebo.
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There were no differences in any parameters from baseline to weeks
36 or 60 among patients who received growth hormone 1-mg or 2-mg
maintenance therapy, nor differences in incidence of most common
adverse events, except for arthralgia (12.5% on 2 mg, 5.7% on 1 mg)
during the 24 weeks that these therapies were administered. It
is reasonable to attempt to maintain previous benefits in lipodystrophy
on a 1 mg/day Serostim dosage.
5. The COLATE Trial – A 48 week
Analysis of a n Open-label, Multi-center Trial to Evaluate the Safety
and Efficacy of Continuing 3TC Twice Daily Versus Discontinuing 3TC
in your Next Medication Combination
- This study sought to evaluate the benefit of continuing to take
3TC (Epivir) despite having developed resistance to it during a previous
failed combination. Many practitioners currently recommend continuing
3TC (Epivir) due to its possible viral weakening effects.
- This study
showed that during one year of follow up, there were equal numbers
of failures in both the group that stayed on Epivir and those that
dropped it from their regimen. There were approximately 65 patients
in each arm of the study. Itis still unclear
whether or not to drop Epivir or continue it in a person’s next
combination.
6. Safety, Tolerability, and
Pharmacokinetics of a Novel, Small-Molecule HIV-1 Attachment Inhibitor, BMS -488043,
after Single and Multiple Oral Doses in Healthy Subjects (#535)
- BMS -488043 is a new attachment
inhibitor molecule that is currently in Phase l/ll trials. It appears
to be safe, well-tolerated, and able to be effectively dosed by
twice daily oral administration.
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