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

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital CRS
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Univ. Med. Ctr. ACTG CRS
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Kessler H

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 315
  • 10688 (Registry Identifier: DAIDS ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Lamivudine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe