Phase I/II study of 3TC (lamivudine) in HIV-positive, asymptomatic or mild AIDS-related complex patients: sustained reduction in viral markers. The Lamivudine European HIV Working Group.

Abstract

OBJECTIVE:

To evaluate the efficacy of 3TC (lamivudine), a synthetic nucleoside analogue that inhibits HIV reverse transcriptase in vitro, as treatment for HIV-positive, asymptomatic or mild AIDS-related complex patients.

DESIGN:

Open-label, multinational and multicentre, non-comparative, escalating dose study.

METHODS:

Patients who meet the selection criteria (n = 104) were enrolled in three European countries. Ten to 15 patients were included at each of the six dose levels of 3TC (0.5, 1.0, 2.0, 4.0, 8.0, 12.0 and 20.0 mg/kg daily in two divided doses every 12 h). Virological parameters--immune-complex dissociation (ICD) assay for HIV p24 antigenaemia, plasma HIV RNA load, whole blood assay and cellular viraemia--were evaluated at weeks 0, 4, 12 and 24.

RESULTS:

Sustained reductions in HIV RNA load and in ICD p24 antigen levels were observed and maintained over the 12-week assessment period. Greater reductions were noted at higher doses but this trend did not reach statistical significance. In 38 patients, reductions of cell viraemia were significantly greater at 4 weeks for patients treated at higher doses of 3TC.

CONCLUSION:

These virological data show that 3TC is a potent inhibitor of HIV replication in HIV-positive, asymptomatic or mild ARC patients as assessed by ICD p24 antigenaemia, plasma HIV RNA load and cell viraemia.

• Authors: D Ingrand, J Weber, C A Boucher, C Loveday, C Robert, A Hill, N Cammack
• Journal: AIDS (London, England) (AIDS) Vol. 9 Issue 12 Pg. 1323-9 (Dec 1995) ISSN: 0269-9370 [Print] England
• PMID: 8605051 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antigen-Antibody Complex
• Antiviral Agents
• HIV Core Protein p24
• Reverse Transcriptase Inhibitors
• Lamivudine
• Zalcitabine

Topics

• AIDS-Related Complex (blood, drug therapy)
• Adult
• Antigen-Antibody Complex (blood)
• Antiviral Agents (therapeutic use)
• Dose-Response Relationship, Drug
• HIV (drug effects)
• HIV Core Protein p24 (immunology)
• HIV Infections (blood, drug therapy)
• HIV Seropositivity (blood, drug therapy)
• Humans
• Lamivudine
• Leukocytes, Mononuclear (virology)
• Male
• Polymerase Chain Reaction
• Reverse Transcriptase Inhibitors (therapeutic use)
• Viremia
• Zalcitabine (analogs & derivatives, therapeutic use)