A Study of Two Anti-HIV Drug Combinations

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002203
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1998
  Purpose

The purpose of this study is to compare the safety and effectiveness of taking lamivudine (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV combination tablet (Combivir) plus a PI. This study also examines how well patients follow the dosing schedules for these drugs.

Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI.


Condition Intervention
HIV Infections
Drug: Lamivudine/Zidovudine
Drug: Lamivudine
Drug: Zidovudine

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter Study of Epivir 150 Mg Bid, Retrovir 200 Mg Tid and a Protease Inhibitor Vs 3TC 150 Mg/ZDV 300 Mg Fixed Dose Tablet Given Bid With a Protease Inhibitor in HIV-Infected Patients

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

It is hypothesized that a fixed-dose 3TC/ZDV tablet given bid in combination with a protease inhibitor is clinically equivalent in its effect on plasma HIV-1 RNA level to a conventional regimen of 3TC, ZDV, and a protease inhibitor.

Patients are stratified according to their current protease inhibitor therapy and randomized to receive open-label therapy of 1 Combivir tablet bid (Arm II) or an equivalent dose of 3TC and ZDV (Arm I), plus their current protease inhibitor for 16 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must have:

  • HIV infection documented by a licensed antibody ELISA assay and confirmed by Western blot, positive HIV blood culture, positive HIV serum antigen, or plasma viremia.
  • CD4+ cell count of at least 300 cells/mm3.
  • HIV-1 RNA less than 10,000 copies/ml by Roche Amplicor PCR assay.
  • CDC Category A or B Classification for HIV infection (no clinical diagnosis of AIDS).
  • Compliance with dosing schedule and protocol evaluations.

Prior Medication:

Required:

  • 3TC at 150 mg bid, ZDV at 600 mg/day (200 mg tid or 300 mg bid), plus a marketed protease inhibitor (ritonavir, saquinavir, indinavir, or nelfinavir) at its recommended dose for at least 10 weeks.

Allowed:

  • Inhaled corticosteroids for the treatment of asthma.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Malabsorption syndromes affecting drug absorption (e.g., Crohn's disease and chronic pancreatitis).
  • Enrollment in other investigational protocols.

Concurrent Medication:

Excluded:

  • Cytotoxic chemotherapeutic agents.
  • Nonnucleoside reverse transcriptase inhibitors.
  • Other investigational agents.

Concurrent Treatment:

Excluded:

Radiation therapy.

Prior Medication:

Excluded:

  • Cytotoxic chemotherapeutic and immunomodulating agents such as systemic corticosteroids, IF-2, alpha-IFN, beta-IFN, or gamma-IFN (except for inhaled corticosteroids for the treatment of asthma) within 4 weeks of study entry.
  • HIV immunotherapeutic vaccine within 3 months of study entry.

Prior Treatment:

Excluded:

Radiation therapy within 4 weeks of study entry.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002203

Locations
United States, California
Pacific Oaks Med Ctr
Beverly Hills, California, United States, 90211
Tower Infectious Diseases / Med Associates Inc
Los Angeles, California, United States, 90048
United States, North Carolina
Univ of North Carolina Hosps
Chapel Hill, North Carolina, United States, 27599
Carolinas Med Ctr
Charlotte, North Carolina, United States, 28232
United States, Virginia
Infectious Diseases Physicians Inc
Annandale, Virginia, United States, 22003
United States, Wisconsin
Univ of Wisconsin School of Medicine
Madison, Wisconsin, United States, 53792
Puerto Rico
San Juan AIDS Program
Santurce, Puerto Rico, 00907
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002203     History of Changes
Other Study ID Numbers: 280A, NZTA4001
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Zidovudine
HIV Protease Inhibitors
CD4 Lymphocyte Count
CD4-CD8 Ratio
Lamivudine
Patient Compliance
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
HIV Protease Inhibitors
Zidovudine
Lamivudine
Reverse Transcriptase Inhibitors
Lamivudine, zidovudine drug combination
Anti-HIV Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antimetabolites
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014