Antiviral Activity of and Resistance to Lamivudine in Combination With Zidovudine, Stavudine, or Didanosine

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

3TC may be uniquely effective in combination with AZT due to the interaction of AZT and 3TC resistance mutations. One explanation is that the M184V mutation, which confers resistance to 3TC, suppresses AZT resistance. This benefit of 3TC may not extend to combination therapy with other nucleoside analogs.

Patients are randomized to either a ddI limb or d4T limb, then randomized a second time to one of six treatment arms, as follows: ddI alone, d4T alone, 3TC/AZT (on both ddI and d4T limbs), 3TC/ddI, and 3TC/d4T. Treatment is given for 48 weeks. At study week 24, patients on monotherapy wil...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • PCP prophylaxis.
• Patients must have:
• • HIV infection.
• • CD4 count 200 - 600 cells/mm3.
• • Life expectancy of at least 24 weeks.
• • Consent of parent or guardian if less than 18 years old.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Unexplained temperature \>= 38.5 C for 7 consecutive days within 30 days prior to study entry.
• PER AMENDMENT 1/25/96:
• • A malignancy that requires systemic chemotherapies other than Kaposi's sarcoma.
• Concurrent Medication:
• Excluded:
• • Concurrent other antiretroviral or immunologic agents.
• • Other experimental therapies.
• • Systemic corticosteroids (except as adjuvant therapy for acute PCP) and other immunosuppressive drugs.
• • Systemic cytotoxic chemotherapy.
• • Induction or maintenance with foscarnet or ganciclovir (oral or IV).
• Patients with the following prior conditions are excluded:
• • History of acute or chronic pancreatitis.
• • History of grade 2 or higher peripheral neuropathy.
• Prior Medication:
• Excluded:
• • Antiretrovirals within 90 days prior to study entry.
• • More than 7 days total lifetime use of any antiretroviral nucleoside.