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

• Status: Completed
• Trial end date: 1998-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy, safety, and pharmacokinetics of lamivudine (3TC) combined with zidovudine (AZT), stavudine (d4T), or didanosine (ddI) in comparison with d4T or ddI monotherapy in HIV-infected patients with no prior nucleoside therapy.

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Antiviral Agents; Didanosine; Lamivudine; Stavudine; Zidovudine

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.