The Effectiveness of Ritonavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients
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| ClinicalTrials.gov Identifier: NCT00001075 |
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Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: February 14, 2012
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To determine whether administration of a highly active antiretroviral treatment regimen consisting of ritonavir (ABT-538), zidovudine (AZT), and lamivudine (3TC) is associated with the restoration of delayed type hypersensitivity and lymphocyte proliferative responses in patients with moderately advanced HIV-1 infection. To better characterize in these patients the phenotype of the expanded lymphocyte subpopulations, as well as the genotype, phenotype, and cellular origin of viruses that persist after initiation of therapy, and the genotype and phenotype of drug-resistant isolates that emerge during therapy.
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Ritonavir Drug: Lamivudine Drug: Zidovudine | Not Applicable |
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.]
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 55 participants |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Completion Date : | July 2007 |
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001075
| United States, Colorado | |
| University of Colorado Hospital CRS | |
| Aurora, Colorado, United States, 80045 | |
| United States, Illinois | |
| Rush Univ. Med. Ctr. ACTG CRS | |
| Chicago, Illinois, United States, 60612 | |
| United States, Ohio | |
| Case CRS | |
| Cleveland, Ohio, United States, 44106 | |
| Study Chair: | Lederman M | ||
| Study Chair: | Kessler H |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001075 History of Changes |
| Other Study ID Numbers: |
ACTG 315 10688 ( Registry Identifier: DAIDS ES ) |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | February 14, 2012 |
| Last Verified: | February 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
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Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents |
Zidovudine HIV Protease Inhibitors Ritonavir Lamivudine |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lamivudine Zidovudine HIV Protease Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Antimetabolites |