1st National Conference Human Retroviruses and Related Infections Washington, DC - December 12-16, 1993

Natl Conf Hum Retrovir Relat Infect 1993 Dec 12-16;1: (abstract no. 9)

Holodniy M¹, Eastman S², Mole L¹, Margolis D¹, Moss J¹, Urdea M², Kolberg J^1
1AIDS Research Center, Veterans Affairs Medical Center, Palo Alto, CA; ²Chiron Corporation, Emeryville, CA

OBJECTIVE: To measure plasma HIV RNA levels and assess the impact of ZDV resistance after the addition of ddI to subjects on long-term ZDV therapy.

METHODS: Seven HIV-infected subjects with CD4 counts less than 200/mm³ (mean 169) and who had been maintained on ZDV therapy for 24-47 months (mean 30 mo), had ddI 200 mg BID added to their regimen. They were followed for 6 months on combination therapy. Plasma HIV RNA was quantitated by the Quantiplex™ HIV-RNA assay based on bDNA technology. The presence of ZDV resistance in plasma RNA was semiquantitated using PCR and differential hybridization for determination of genotype at the aa215 and aa74 loci.

RESULTS: All seven patients tolerated the combination regimen well. One subject experienced an outbreak of anogenital herpes during the time of observation, otherwise no clinical progression or OI development was seen. As a group, CD4 count increased from a mean of 169±33 to 228±57 and 267±85 mm3 at 3 and 6 mo respectively. Patients with essentially 100% aa215 mutation at baseline demonstrated little decline in total plasma RNA levels. Patients with a significant portion of aa215 wild type at baseline, demonstrated a significant decline in total plasma RNA levels. However, after 6 mo of combination therapy, residual plasma RNA was predominantly aa215 mutant in these subjects. In addition, no aa74 mutations were detected after 6 mo of combination therapy.

CONCLUSIONS: The addition of ddI to ZDV therapy is well tolerated and results in significant falls in plasma RNA as assessed by bDNA assay and significant increases in CD4 count for at least 6 months. Preliminary data suggest that the presence of ZDV resistant virus in plasma is not affected by the addition of ddI.

Keywords: Acquired Immunodeficiency Syndrome, Anti-HIV Agents, Antigens, CD4, CD4 Lymphocyte Count, Combined Modality Therapy, Didanosine, Disease Progression, HIV, HIV Infections, HIV Seropositivity, Humans, Zidovudine, immunology, organization & administration

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1993-12-12
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