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Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Indinavir sulfate
Ritonavir
Lamivudine
Stavudine
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Ritonavir, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

Eligibility Criteria

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

Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have a CD4 cell count of 75 cells/mm3 or more and a viral load of 5,000 copies/ml or more. Are age 16 or older (consent of a parent or guardian required if under 18). Agree to practice abstinence or use barrier methods of birth control (such as condoms). Are willing to stop taking all anti-HIV drugs except study drugs. (Patients may be able to continue taking drugs for other infections.) Exclusion Criteria Patients will not be eligible for this study if they: Have cancer, lung disease, severe hepatitis, or active AIDS-related infections. (Certain AIDS-related infections such as Kaposi's sarcoma may be allowed). Have ever taken 3TC, abacavir (ABC), or a protease inhibitor (such as IDV or RTV). Have changed their medications in the last 2 weeks. Are allergic to IDV, RTV, d4T, or 3TC. Have used certain medications (see the technical summary for more detail). Are pregnant or breast-feeding.

Sites / Locations

  • Univ of Alabama at Birmingham
  • Apogee Med Group
  • Univ of California at San Francisco Gen Hosp
  • HIV Institute / Davies Med Ctr
  • Kaiser Foundation Hospital
  • Univ of Miami School of Medicine
  • AIDS Research Alliance - Chicago
  • Tulane Univ School of Medicine
  • CRI New England
  • Bronx Lebanon Hosp Ctr
  • Montefiore Med Ctr
  • SUNY Health Sciences Ctr
  • Chelsea Village Med Ctr
  • Liberty Med Group
  • St Lukes / Roosevelt Hosp / HIV Center
  • Mount Sinai Med Ctr
  • Mark Watkins
  • Univ of Texas / Thomas Street Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00002241
Brief Title
Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily
Official Title
A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Efficacy of Indinavir Sulfate 800 Mg b.i.d. in Combination With Ritonavir 100 Mg/d4T/3TC b.i.d. in HIV-Infected Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
July 2001
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV in the blood.
Detailed Description
Patients take IDV plus RTV plus d4T plus 3TC twice daily for 24 weeks. Every 4 weeks, patients have physical exams and laboratory tests of blood and urine, and CD4 cell counts and plasma viral RNA are measured. At Week 24, the proportion of patients with plasma viral RNA below 400 copies/ml is determined to identify any clinically meaningful antiretroviral activity for the drug regimen. An observed response proportion of 80% or higher will be considered clinically meaningful.

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, Stavudine, HIV Protease Inhibitors, Ritonavir, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Stavudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have a CD4 cell count of 75 cells/mm3 or more and a viral load of 5,000 copies/ml or more. Are age 16 or older (consent of a parent or guardian required if under 18). Agree to practice abstinence or use barrier methods of birth control (such as condoms). Are willing to stop taking all anti-HIV drugs except study drugs. (Patients may be able to continue taking drugs for other infections.) Exclusion Criteria Patients will not be eligible for this study if they: Have cancer, lung disease, severe hepatitis, or active AIDS-related infections. (Certain AIDS-related infections such as Kaposi's sarcoma may be allowed). Have ever taken 3TC, abacavir (ABC), or a protease inhibitor (such as IDV or RTV). Have changed their medications in the last 2 weeks. Are allergic to IDV, RTV, d4T, or 3TC. Have used certain medications (see the technical summary for more detail). Are pregnant or breast-feeding.
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Apogee Med Group
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Univ of California at San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
HIV Institute / Davies Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Kaiser Foundation Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
AIDS Research Alliance - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Tulane Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
CRI New England
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02146
Country
United States
Facility Name
Bronx Lebanon Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10456
Country
United States
Facility Name
Montefiore Med Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
SUNY Health Sciences Ctr
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Chelsea Village Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10014
Country
United States
Facility Name
Liberty Med Group
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
St Lukes / Roosevelt Hosp / HIV Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mark Watkins
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Univ of Texas / Thomas Street Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily

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