A Pilot Study to Evaluate the Immunologic Consequences of a Highly Active Antiretroviral Therapy Regimen (HAART) Consisting of Ritonavir (ABT-538), Zidovudine (AZT), and Lamivudine (3TC) in Moderately Advanced HIV-1 Disease
Ritonavir
+ Lamivudine
+ Zidovudine
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
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: The availability of the current, open-label study treatment has been extended to allow patients who have completed 48 weeks of therapy to continue protocol therapy until the last enrolled patient completes 48 weeks of study treatment.]
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.55 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
University of Colorado Hospital CRS
Aurora, United StatesOpen University of Colorado Hospital CRS in Google MapsRush Univ. Med. Ctr. ACTG CRS
Chicago, United StatesCase CRS
Cleveland, United States