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The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Indinavir sulfate
Lamivudine
Stavudine
Zidovudine
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Drug Therapy, Combination, Stavudine, Lamivudine, RNA, Viral, Anti-HIV Agents, Viral Load

Eligibility Criteria

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

Inclusion Criteria Patients must have: At least six months of prior cumulative ZDV therapy. Qualifying plasma HIV RNA count of >= 4 log10 copies/ml obtained within 2 weeks of randomization. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Presence of newly diagnosed AIDS defining opportunistic infection requiring acute therapy at time of enrollment. Intractable diarrhea (>= 6 loose stools/day for >= 7 consecutive days). Signs and symptoms of bilateral peripheral neuropathy >= grade 2 at the time of screening. Inability to tolerate oral medication. Any other clinical conditions that in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements. Concurrent Medication: Excluded: Therapy with agents with systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential. Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole at any time while on indinavir therapy. Patients with any of the following prior conditions or symptoms are excluded: History of acute or chronic pancreatitis. Prior history of bilateral peripheral neuropathy. Intractable diarrhea (>= 6 loose stools/day for >= 7 consecutive days) within 30 days prior to study entry. Prior Medication: Excluded: Any prior antiretroviral therapy except for ddI, ddC, 3TC or ZDV (for ZDV, as specified in inclusion criteria). Previous therapy with agents with significant systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start. Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole within 2 weeks prior to starting indinavir. Any other prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing regimen. Risk Behavior: Excluded: Active alcohol abuse, sufficient in the investigator's opinion, to prevent compliance with study therapy or to increase the risk of developing pancreatitis. Required: At least 6 months of prior cumulative ZDV therapy.

Sites / Locations

  • Harbor UCLA Med Ctr
  • Univ of South Florida
  • SUNY at Stony Brook / Division of Infectious Diseases
  • Houston Clinical Research Network / Div of Montrose Clinic
  • Univ of Utah / School of Medicine / Div of Infect Dis
  • Sunnybrook Health Science Ctr
  • Montreal Gen Hosp / Div of Clin Immuno and Allergy
  • Univ of Puerto Rico School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
April 28, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00002371
Brief Title
The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine
Official Title
A Randomized Double-Blind Study of Safety, Virologic and Immunological Effects of Stavudine Plus Lamivudine (3TC) Versus Zidovudine Plus Lamivudine in HIV-Infected Subjects Following At Least Six Months of Zidovudine Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
June 1996 (undefined)
Primary Completion Date
December 1997 (Actual)
Study Completion Date
December 1997 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
To compare the magnitude and durability of the reduction in plasma HIV RNA in the two treatment groups over the first 12 weeks of treatment. To determine the safety of each of the two treatment groups.
Detailed Description
Patients will be randomized to either Stavudine (d4T) + Lamivudine (3TC) + Zidovudine placebo or Zidovudine (ZDV) + Lamivudine + Stavudine placebo. Patients whose plasma HIV RNA levels remain >= 500 copies/ml after 8 weeks of blinded double combination therapy will have indinavir added to their treatment regimen at the week 12 visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Drug Therapy, Combination, Stavudine, Lamivudine, RNA, Viral, Anti-HIV Agents, Viral Load

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Stavudine
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: At least six months of prior cumulative ZDV therapy. Qualifying plasma HIV RNA count of >= 4 log10 copies/ml obtained within 2 weeks of randomization. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Presence of newly diagnosed AIDS defining opportunistic infection requiring acute therapy at time of enrollment. Intractable diarrhea (>= 6 loose stools/day for >= 7 consecutive days). Signs and symptoms of bilateral peripheral neuropathy >= grade 2 at the time of screening. Inability to tolerate oral medication. Any other clinical conditions that in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements. Concurrent Medication: Excluded: Therapy with agents with systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential. Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole at any time while on indinavir therapy. Patients with any of the following prior conditions or symptoms are excluded: History of acute or chronic pancreatitis. Prior history of bilateral peripheral neuropathy. Intractable diarrhea (>= 6 loose stools/day for >= 7 consecutive days) within 30 days prior to study entry. Prior Medication: Excluded: Any prior antiretroviral therapy except for ddI, ddC, 3TC or ZDV (for ZDV, as specified in inclusion criteria). Previous therapy with agents with significant systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start. Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole within 2 weeks prior to starting indinavir. Any other prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing regimen. Risk Behavior: Excluded: Active alcohol abuse, sufficient in the investigator's opinion, to prevent compliance with study therapy or to increase the risk of developing pancreatitis. Required: At least 6 months of prior cumulative ZDV therapy.
Facility Information:
Facility Name
Harbor UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Univ of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
SUNY at Stony Brook / Division of Infectious Diseases
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Houston Clinical Research Network / Div of Montrose Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Univ of Utah / School of Medicine / Div of Infect Dis
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Sunnybrook Health Science Ctr
City
North York
State/Province
Ontario
Country
Canada
Facility Name
Montreal Gen Hosp / Div of Clin Immuno and Allergy
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Univ of Puerto Rico School of Medicine
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine

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