A Study of Two Anti-HIV Drug Combinations

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002203

Run by

Glaxo Wellcome

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pacific Oaks Med Ctr — Beverly Hills, California, United States
• Tower Infectious Diseases / Med Associates Inc — Los Angeles, California, United States
• Univ of North Carolina Hosps — Chapel Hill, North Carolina, United States
• Carolinas Med Ctr — Charlotte, North Carolina, United States
• Infectious Diseases Physicians Inc — Annandale, Virginia, United States
• Univ of Wisconsin School of Medicine — Madison, Wisconsin, United States
• San Juan AIDS Program — Santurce, Puerto Rico

Full record on ClinicalTrials.gov

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