Clinical trial NCT00002241: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Stavudine
HIV Protease Inhibitors
Ritonavir
Lamivudine
Indinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: Apogee Med Group
state: California
city: San Francisco
country: United States
facility: Univ of California at San Francisco Gen Hosp
state: California
city: San Francisco
country: United States
facility: HIV Institute / Davies Med Ctr
state: California
city: San Francisco
country: United States
facility: Kaiser Foundation Hospital
state: California
city: Miami
country: United States
facility: Univ of Miami School of Medicine
state: Florida
city: Chicago
country: United States
facility: AIDS Research Alliance - Chicago
state: Illinois
city: New Orleans
country: United States
facility: Tulane Univ School of Medicine
state: Louisiana
city: Brookline
country: United States
facility: CRI New England
state: Massachusetts
city: Bronx
country: United States
facility: Bronx Lebanon Hosp Ctr
state: New York
city: Bronx
country: United States
facility: Montefiore Med Ctr
state: New York
city: Brooklyn
country: United States
facility: SUNY Health Sciences Ctr
state: New York
city: New York
country: United States
facility: Chelsea Village Med Ctr
state: New York
city: New York
country: United States
facility: Liberty Med Group
state: New York
city: New York
country: United States
facility: St Lukes / Roosevelt Hosp / HIV Center
state: New York
city: New York
country: United States
facility: Mount Sinai Med Ctr
state: New York
city: Philadelphia
country: United States
facility: Mark Watkins
state: Pennsylvania
city: Houston
country: United States
facility: Univ of Texas / Thomas Street Clinic
state: Texas
Study officials:
References: