A Study of Two Anti-HIV Drug Combinations
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Lamivudine/Zidovudine (Drug); Lamivudine (Drug); Zidovudine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Glaxo Wellcome
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.
Clinical Details
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 design: Treatment, Parallel Assignment, Safety Study
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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.
Locations and Contacts
San Juan AIDS Program, Santurce 00907, Puerto Rico
Tower Infectious Diseases / Med Associates Inc, Los Angeles, California 90048, United States
Pacific Oaks Med Ctr, Beverly Hills, California 90211, United States
Univ of North Carolina Hosps, Chapel Hill, North Carolina 27599, United States
Carolinas Med Ctr, Charlotte, North Carolina 28232, United States
Infectious Diseases Physicians Inc, Annandale, Virginia 22003, United States
Univ of Wisconsin School of Medicine, Madison, Wisconsin 53792, United States
Additional Information
Last updated: June 23, 2005
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