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.

Condition	Treatment or Intervention
HIV Infections	Drug: Lamivudine/Zidovudine  Drug: Lamivudine  Drug: Zidovudine

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

California
      Tower Infectious Diseases / Med Associates Inc, Los Angeles,  California,  90048,  United States
      Pacific Oaks Med Ctr, Beverly Hills,  California,  90211,  United States
North Carolina
      Univ of North Carolina Hosps, Chapel Hill,  North Carolina,  27599,  United States
      Carolinas Med Ctr, Charlotte,  North Carolina,  28232,  United States
Virginia
      Infectious Diseases Physicians Inc, Annandale,  Virginia,  22003,  United States
Wisconsin
      Univ of Wisconsin School of Medicine, Madison,  Wisconsin,  53792,  United States
Puerto Rico
      San Juan AIDS Program, Santurce,  00907,  Puerto Rico

Study ID Numbers:  280A; NZTA4001
Record last reviewed:  November 1998
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002203
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08