The Effectiveness of Ritonavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients

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

Keywords

ClinConnect Summary

Although plasma viral load drops dramatically after initiation of powerful antiretrovirals, it does not drop to zero. It appears that a new steady state is reached, suggesting that a reservoir may exist of virus-producing cells, possibly cells of monocyte/macrophage lineage, that continue to produce a low level of virus despite antiretroviral treatment.

Patients undergo 5 weeks of antiretroviral washout before initiating therapy with ritonavir alone for 9 days, followed by combination therapy with ritonavir, zidovudine, and lamivudine from day 10 through week 48. \[AS PER AMENDMENT 1/31/97...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Recombinant erythropoietin and/or G-CSF for AZT-related bone marrow suppression.
• • Antibiotics other than metronidazole.
• • PCP prophylaxis.
• • Regularly prescribed medications such as antipyretics, analgesics, allergy medicine, and oral contraceptives.
• • Vitamins and herbal therapies.
• Concurrent Treatment:
• Allowed:
• • Acupuncture.
• • Visualization techniques.
• Patients must have:
• • Documented HIV infection.
• • CD4 count 100-300 cells/mm3.
• • At least 3 consecutive months of prior AZT at a dosage of 500-600 mg bid, but with 5 weeks of antiretroviral washout prior to study entry.
• • Consent of parent or guardian if less than 18 years old.
• Prior Medication:
• Required:
• • Prior AZT at 500-600 mg bid at any time.
• • PCP prophylaxis during antiretroviral washout.
• Allowed:
• • Prior ddI and/or ddC.
• • Prior recombinant erythropoietin and/or G-CSF for AZT-related bone marrow suppression.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Chronic pancreatitis.
• • Psychological conditions that would affect compliance.
• • Intolerance to 500-600 mg/day AZT.
• • Concurrent participation on another antiretroviral research treatment study (study treatment for opportunistic infection or complications of HIV is allowed).
• • Considered likely to be noncompliant on study.
• Concurrent Medication:
• Excluded:
• • Immunomodulators such as systemic corticosteroids, thalidomide, or cytokines.
• • Rifabutin.
• • Disulfiram (Antabuse) or other medications with similar effects, including metronidazole.
• • Other drugs contraindicated with ritonavir.
• • \[AS PER AMENDMENT 8/27/96: Immunization must be avoided during the antiretroviral washout period.\]
• Patients with the following prior conditions are excluded:
• • Active opportunistic infection or febrile illness with temperature \>= 38.5 C within 3 days prior to study entry.
• • History of acute pancreatitis within the past 2 years.
• Prior Medication:
• Excluded:
• • Prior 3TC or a protease inhibitor.
• • Experimental drugs except those for HIV-related conditions, within the past 30 days.
• • \[AS PER AMENDMENT 8/27/96: Immunization must be avoided prior to the antiretroviral washout period.\]
• • Active substance abuse.

Trial Officials