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The Body Covers: The 39th Annual Meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy
Poster Session 192.I: Clinical Trials of Antiretroviral Therapy

Tuesday, September 28, 1999

Paper No. 1973: Comparison of a Triple Regimen Containing Once-Daily Didanosine vs a Regimen of ZDV/3TC/NLF

Paper No. 1975: Multicenter, Randomized Phase II Trial of Multiple Doses of Lodenosine in Combination with Stavudine and Indinavir in Antiretroviral-Naïve HIV-Infected Adults

Paper No. 1982: Efficacy of Efavirenz in Combination with Stavudine (d4T) and Didanosine (ddI) in Antiretroviral Therapy-Naïve HIV-Infected Patients (Study 044)


This session was devoted to the comparison of various HAART regimens and different dosing strategies.


Paper No. 1973: Comparison of a Triple Regimen Containing Once-Daily Didanosine vs a Regimen of ZDV/3TC/NLF

Authored by C. McLaren, et al.
Coverage provided by Mark Holodniy, M.D.

Poster 1973 looked at the efficacy and toxicity of a once daily ddI-containing regimen compared to standard therapy. The study cohort were drug naïve patients with a CD4 count of >100 and detectable viral load. The treatment regimens were: ddI 400 mg once daily/d4T 40mg twice daily/nelfinavir 750mg three times daily versus ZDV 300mg twice daily/3TC 150 mg twice daily/nelfinavir 750 mg three times daily. Study duration was 24 weeks. The ddI formulation was a 200mg tablet, not the standard 100mg tablet. Thus the total ddI tablets per day were 2 and not 4. Efficacy data was available for 375 patients and safety data in 725 patients. Both regimens decreased viral load by a mean of 2 log/ml (100 fold reduction). In terms of achieving an undetectable viral load, 79% of the ddI and 73% of the ZDV arm patients in the on treatment analysis (OT) and 63% of the ddI and 57% of the ZDV arm in the intent to treat (ITT, missing = failure) analysis demonstrated an undetectable viral load at week 24. CD4 count increased by 170 cells in both groups. The incidence of serious side effects was fairly equal in both groups. The ddI regimen tended to have more liver and pancreas enzyme abnormalities (1 case of pancreatitis, 2 cases of peripheral neuropathy requiring discontinuation) and the ZDV regimen had more nausea and lower white blood cell abnormalities. The conclusions from this study are: a once daily ddI-containing regimen is as effective as a ZDV/3TC regimen, and that 2, 200mg tablets are as effective as 4, 100mg ddI tablets. This should greatly improve tolerability and adherence to ddI containing regimens.


Paper No. 1975: Multicenter, Randomized Phase II Trial of Multiple Doses of Lodenosine in Combination with Stavudine and Indinavir in Antiretroviral-Naïve HIV-Infected Adults

Authored by B. Young, et al.
Coverage provided by Mark Holodniy, M.D.

Poster 1975 described results from a multi-center phase 2 trial of lodenosine (fddA) in combination with d4T and indinavir. Lodenosine (FddA) is a purine NRTI that resembles ddA except for the addition of a fluorine molecule. Fluorine makes the compound more stable in an acid environment. Thus, buffers or antacid are not required for good oral absorption as they would be for the current formulation of ddI. The study group consisted of drug naïve patients with a mean baseline CD4 count of 421 and viral load of 4.6 log/ml. There were four treatment arms. Arms 1 to 3 included regimens of d4T and indinavir in standard doses with doses of 100mg, 200mg and 300mg twice daily of lodenosine respectively. Arm 4 was a control arm where the regimen was 3TC/d4T/indinavir in standard doses. Data from 66 patients followed for 12 weeks was presented. By week 12, the mean reduction in viral load for all three lodenosine arms was 2.5 log/ml. This was not significantly different than the control arm. The proportion of patients with <50 copies/ml viral load was not significantly different between arms (50-59%). Mean increase in CD4 appeared to be greatest in the 100mg lodenosine arm compared to the other two arms, and equaled that of the control arm. Overall adverse reactions were similar in the lodenosine arms (which were lumped together) compared to the control arm. The only serious adverse event that was significantly different compared to the control arm was hyperbilirubinemia. The conclusions from this study are that lodenosine is very active at all doses studied, with a background of d4T and indinavir. It appears to be relatively well tolerated. Follow-up data will be required to determine the durability of this response.


Paper No. 1982: Efficacy of Efavirenz in Combination with Stavudine (d4T) and Didanosine (ddI) in Antiretroviral Therapy-Naïve HIV-Infected Patients (Study 044)

Authored by D. Ward, et al.
Coverage provided by Mark Holodniy, M.D.

Poster 1982 described the results of a multi-center study (Study 044) that looked at the regimen of efavirenz, d4T, and ddI. Previous studies have looked at regimens that combined efavirenz with 3TC/d4T or ZDV/3TC. This study group consisted of drug naïve patients with a mean baseline CD4 count of 289 and viral load of 4.90 log/ml. There was only one treatment arm and follow-up will be for 48 weeks. ddI was administered as a 250/400mg dose once daily. In the ITT analysis, 75% of patients had a viral load <400/ml and 67% had a viral load of <50/ml by 24 weeks. In the 25 patients with a baseline viral load of >100,000/ml, 67% had a 24 week viral load that was <50/ml. CD4 cell count increased 123 cells at 24 weeks. Mild to moderate rash was seen in 10/53. Median onset was at 10 days and lasted 6 days. Only one person required discontinuation. Nervous system symptoms were seen in 22/53. Median onset was one day and lasted 14 days (range 1 to >167 days). Only one person required discontinuation. Only 2 patients had significant peripheral neuropathy. The conclusions from this study are that the combination of ddI/d4T/efavirenz is very potent, and appears to be as effective as other efavirenz or protease inhibitor regimens, which contain ZDV/3TC or d4T/3TC. Toxicity profile appears acceptable. Follow-up data will be required to determine the durability of this response.



  
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Please note: Knowledge about HIV changes rapidly. Note the date of this summary's publication, and before treating patients or employing any therapies described in these materials, verify all information independently. If you are a patient, please consult a doctor or other medical professional before acting on any of the information presented in this summary. For a complete listing of our most recent conference coverage, click here.

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