Clinical trial NCT00002203: A Study of Two Anti-HIV Drug Combinations
Official title: A Randomized, Multicenter Study of Epivir 150 Mg Bid, Retrovir 200 Mg Tid and a Protease Inhibitor Vs 3TC 150 Mg/ZDV 300 Mg Fixed Dose Tablet Given Bid With a Protease Inhibitor in HIV-Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Zidovudine
HIV Protease Inhibitors
CD4 Lymphocyte Count
CD4-CD8 Ratio
Lamivudine
Patient Compliance
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
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
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and effectiveness of taking lamivudine (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV combination tablet (Combivir) plus a PI. This study also examines how well patients follow the dosing schedules for these drugs.

Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI.

Detailed description: It is hypothesized that a fixed-dose 3TC/ZDV tablet given bid in combination with a protease inhibitor is clinically equivalent in its effect on plasma HIV-1 RNA level to a conventional regimen of 3TC, ZDV, and a protease inhibitor.

Patients are stratified according to their current protease inhibitor therapy and randomized to receive open-label therapy of 1 Combivir tablet bid (Arm II) or an equivalent dose of 3TC and ZDV (Arm I), plus their current protease inhibitor for 16 weeks.

Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV infection documented by a licensed antibody ELISA assay and confirmed by Western blot, positive HIV blood culture, positive HIV serum antigen, or plasma viremia.
* CD4+ cell count of at least 300 cells/mm3.
* HIV-1 RNA less than 10,000 copies/ml by Roche Amplicor PCR assay.
* CDC Category A or B Classification for HIV infection (no clinical diagnosis of AIDS).
* Compliance with dosing schedule and protocol evaluations.

Prior Medication:

Required:

* 3TC at 150 mg bid, ZDV at 600 mg/day (200 mg tid or 300 mg bid), plus a marketed protease inhibitor (ritonavir, saquinavir, indinavir, or nelfinavir) at its recommended dose for at least 10 weeks.

Allowed:

* Inhaled corticosteroids for the treatment of asthma.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Malabsorption syndromes affecting drug absorption (e.g., Crohn's disease and chronic pancreatitis).
* Enrollment in other investigational protocols.

Concurrent Medication:

Excluded:

* Cytotoxic chemotherapeutic agents.
* Nonnucleoside reverse transcriptase inhibitors.
* Other investigational agents.

Concurrent Treatment:

Excluded:

Radiation therapy.

Prior Medication:

Excluded:

* Cytotoxic chemotherapeutic and immunomodulating agents such as systemic corticosteroids, IF-2, alpha-IFN, beta-IFN, or gamma-IFN (except for inhaled corticosteroids for the treatment of asthma) within 4 weeks of study entry.
* HIV immunotherapeutic vaccine within 3 months of study entry.

Prior Treatment:

Excluded:

Radiation therapy within 4 weeks of study entry.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Pacific Oaks Med Ctr
state: California
city: Los Angeles
country: United States
facility: Tower Infectious Diseases / Med Associates Inc
state: California
city: Chapel Hill
country: United States
facility: Univ of North Carolina Hosps
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Med Ctr
state: North Carolina
city: Annandale
country: United States
facility: Infectious Diseases Physicians Inc
state: Virginia
city: Madison
country: United States
facility: Univ of Wisconsin School of Medicine
state: Wisconsin
city: Santurce
country: Puerto Rico
facility: San Juan AIDS Program
Study officials:
References: