The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine

Launched by BRISTOL-MYERS SQUIBB · Aug 30, 2001

Keywords

ClinConnect Summary

Patients will be randomized to either Stavudine (d4T) + Lamivudine (3TC) + Zidovudine placebo or Zidovudine (ZDV) + Lamivudine + Stavudine placebo. Patients whose plasma HIV RNA levels remain \>= 500 copies/ml after 8 weeks of blinded double combination therapy will have indinavir added to their treatment regimen at the week 12 visit.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • At least six months of prior cumulative ZDV therapy.
• • Qualifying plasma HIV RNA count of \>= 4 log10 copies/ml obtained within 2 weeks of randomization.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with any of the following symptoms or conditions are excluded:
• • Presence of newly diagnosed AIDS defining opportunistic infection requiring acute therapy at time of enrollment.
• • Intractable diarrhea (\>= 6 loose stools/day for \>= 7 consecutive days).
• • Signs and symptoms of bilateral peripheral neuropathy \>= grade 2 at the time of screening.
• • Inability to tolerate oral medication.
• • Any other clinical conditions that in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements.
• Concurrent Medication:
• Excluded:
• • Therapy with agents with systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential.
• • Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole at any time while on indinavir therapy.
• Patients with any of the following prior conditions or symptoms are excluded:
• • History of acute or chronic pancreatitis.
• • Prior history of bilateral peripheral neuropathy.
• • Intractable diarrhea (\>= 6 loose stools/day for \>= 7 consecutive days) within 30 days prior to study entry.
• Prior Medication:
• Excluded:
• • Any prior antiretroviral therapy except for ddI, ddC, 3TC or ZDV (for ZDV, as specified in inclusion criteria).
• • Previous therapy with agents with significant systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start.
• • Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole within 2 weeks prior to starting indinavir.
• • Any other prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing regimen.
• Risk Behavior:
• Excluded:
• • Active alcohol abuse, sufficient in the investigator's opinion, to prevent compliance with study therapy or to increase the risk of developing pancreatitis.
• Required:
• • At least 6 months of prior cumulative ZDV therapy.