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A Comparison of Two Dose Levels of Indinavir Combined with Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients



A Comparison of Two Dose Levels of Indinavir Combined with Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients

For Condition: HIV Infections
Status: Completed
Sponsor(s): Merck Research Laboratories ,
Synopsis: The purpose of this study is to determine if two dose levels of indinavir combined with two nucleoside analogue reverse transcriptase inhibitors (NRTIs) have the same effect on plasma viral load (level of HIV in the blood).
Details: In this open-label study 350 seropositive HIV-1 men and women are first stratified according to baseline plasma viral RNA (less than 400 copies/mL vs negative plasma viral RNA result) then randomized into one of two arms: Arm 1: Indinavir (800 mg, q8h) plus two pre-existing NRTIs. Arm 2: Indinavir (1,200 mg, q12h) plus two pre-existing NRTIs. Plasma viral RNA will be measured every 4 weeks for the duration of the 24-week study.
Eligibility:
Study Type:
  Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Documented HIV-1 seropositive status. - CD4 count greater than 100 cells/mm3. - Parental consent for patients under 18.
Total Enrollment: 350

Location and Contact Information:

Tower ID Med Associates
Los Angeles,  California,  90048
United States
 

San Francisco Gen Hosp / UCSF AIDS Program
San Francisco,  California,  94110
United States
 

1917 Research Clinic
Birmingham,  Alabama,  35294
United States
 

Anderson Clinical Research
New York City,  New York,  10016
United States
 

Univ of Miami School of Medicine
Miami,  Florida,  33136
United States
 

Univ of Utah School Of Medicine / Div of Infec Disease
Salt Lake City,  Utah,  84132
United States
 

Natl Naval Med Ctr / Special Immunology Clinic
Bethesda,  Maryland,  20889
United States
 

SUNY / Health Science Ctr at Brooklyn
Brooklyn,  New York,  11203
United States
 

Education & Research Building
Camden,  New Jersey,  08103
United States
 

Akron City Hospital
Akron,  Ohio,  44304
United States
 

Univ Health Ctr 7D
Detroit,  Michigan,  48201
United States
 

Kansas City Free Health Clinic
Kansas City,  Missouri,  64111
United States
 

AIDS Research Consortium of Atlanta
Atlanta,  Georgia,  30308
United States
 

Garden State Infectious Diseases / E I P Kennedy Health Sys
Voorhees,  New Jersey,  08043
United States
 

HIV Clinical Research
Ft. Lauderdale,  Florida,  33316
United States
 

CRIA
New York City,  New York,  10001
United States
 

Brigham and Women's Hosp
Boston,  Massachusetts,  02115
United States
 

St Vincents Hosp and Med Ctr / Div of HIV Med
New York City,  New York,  10011
United States
 

Albany Med College / Div of HIV Medicine
Albany,  New York,  12208
United States
 

Boston Med Ctr / Clinical Research Office
Boston,  Massachusetts,  02118
United States
 

Rush Presbyterian St Lukes Med Ctr
Chicago,  Illinois,  60612
United States
 

Northwestern Univ Med School
Chicago,  Illinois,  60611
United States
 

New York Hosp of Queens / AIDS Ctr
Flushing,  New York,  11355
United States
 

Ctr for AIDS Research / Education and Service (CARES)
Sacramento,  California,  95814
United States
 

Kaiser Permanente / Infectious Disease
Los Angeles,  California,  90027
United States
 

Houston Clinical Research Network / Southhampton Med Group
Houston,  Texas,  77098
United States
 

Thomas Jefferson Univ
Philadelphia,  Pennsylvania,  19107
United States
 

Ponce de Leon Ctr
Atlanta,  Georgia,  30308
United States
 

Anderson Clinical Research
Pittsburgh,  Pennsylvania,  15213
United States
 


Additional Information:
Study ID Numbers:
  246P;  MK-0639
Study Start Date: 
Record last reviewed: June 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002406

Other Hiv Infections Studies:
1. Phase II Study of the Safety and Surrogate Marker Efficacy of Butyldeoxynojirimycin (SC-48334) and AZT in Symptomatic HIV-1 Infected Patients with 200 - 500 CD4+ Cells/mm3. (NOTE: Asymptomatic HIV-1 Infected Patients Also Eligible)

2. A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment

3. The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients with Early HIV Infection

4. A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants

5. A Multi-Center Clinical Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS Post First Episode PCP

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A Comparison of Two Dose Levels of Indinavir Combined with Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients

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