search
Back to results

A Study of Two Anti-HIV Drug Combinations

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lamivudine/Zidovudine
Lamivudine
Zidovudine
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, CD4 Lymphocyte Count, CD4-CD8 Ratio, Lamivudine, Patient Compliance, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pacific Oaks Med Ctr
  • Tower Infectious Diseases / Med Associates Inc
  • Univ of North Carolina Hosps
  • Carolinas Med Ctr
  • Infectious Diseases Physicians Inc
  • Univ of Wisconsin School of Medicine
  • San Juan AIDS Program

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
search

1. Study Identification

Unique Protocol Identification Number
NCT00002203
Brief Title
A Study of Two Anti-HIV Drug Combinations
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, CD4 Lymphocyte Count, CD4-CD8 Ratio, Lamivudine, Patient Compliance, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lamivudine/Zidovudine
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Pacific Oaks Med Ctr
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Tower Infectious Diseases / Med Associates Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Univ of North Carolina Hosps
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolinas Med Ctr
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232
Country
United States
Facility Name
Infectious Diseases Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Univ of Wisconsin School of Medicine
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
San Juan AIDS Program
City
Santurce
ZIP/Postal Code
00907
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

A Study of Two Anti-HIV Drug Combinations

We'll reach out to this number within 24 hrs