Clinical trial NCT00002442: A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs
Official title: A Phase II, Open-Label, Randomized Study of the Efficacy and Safety of Epivir 150 Mg BID Versus Epivir 300 Mg Once-Daily When Administered for 24 Weeks in Combination With FDA-Approved Dosage Regimens of Zerit and Either Crixivan or Viracept in Subjects With HIV-1 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Zidovudine
Drug Administration Schedule
Stavudine
HIV Protease Inhibitors
Lamivudine
Indinavir
Dosage Forms
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules (once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either indinavir (IDV) or nelfinavir (NFV) for 24 weeks.

Detailed description: Patients are randomized to 1 of 2 groups. Group 1 receives 3TC qd plus d4T plus either IDV or NFV. Group 2 receives 3TC bid plus d4T plus either IDV or NFV. Patients are evaluated for drug tolerance, medication adherence, and genotypic and phenotypic resistance.

Eligibility criteria: Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Are at least 18 years old.
* Have had an HIV level below 400 copies/ml for at least 3 months prior to study entry.
* Have a CD4 cell count of at least 50 cells/mm3.
* Are currently taking an anti-HIV drug regimen that includes 3TC plus d4T plus either IDV or NFV for at least 6 months prior to study entry. (Note: This must be their first anti-HIV drug regimen.)
* Agree to abstain from sex or use effective methods of birth control during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have a history of an AIDS-defining illness or certain other medical conditions.
* Are allergic to any of the study drugs.
* Are unable to take medication by mouth for any reason.
* Have received certain medications.
* Will need to receive radiation therapy or chemotherapy (for any cancer other than Kaposi's sarcoma) during the study.
* Are pregnant or breast-feeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation
state: California
city: Palo Alto
country: United States
facility: Palo Alto Veterans Affairs Health Care System
state: California
city: Washington
country: United States
facility: Dupont Circle Physicians Group
state: District of Columbia
city: Altamonte Springs
country: United States
facility: IDC Research Initiative
state: Florida
city: Fort Lauderdale
country: United States
facility: North Broward Hosp District
state: Florida
city: Miami
country: United States
facility: Steinhart Medical Associates
state: Florida
city: Chicago
country: United States
facility: Northwestern Univ Med School
state: Illinois
city: New York
country: United States
facility: Saint Vincents Hosp
state: New York
city: New York
country: United States
facility: St Lukes - Roosevelt Hosp Ctr
state: New York
city: Philadelphia
country: United States
facility: MCP Hahnemann Univ Hosp
state: Pennsylvania
city: Dallas
country: United States
facility: Southwest Infectious Disease Association / PA
state: Texas
city: Galveston
country: United States
facility: Univ TX Galveston Med Branch
state: Texas
Study officials:
References: