A Study of Two Anti-HIV Drug Combinations

Sponsor

Glaxo Wellcome (Industry)

Overall Status

Completed

CT.gov ID

NCT00002203

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Lamivudine/Zidovudine Drug: Lamivudine Drug: Zidovudine	N/A

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.

Study Design

Study Type:

Interventional

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pacific Oaks Med Ctr	Beverly Hills	California	United States	90211
2	Tower Infectious Diseases / Med Associates Inc	Los Angeles	California	United States	90048
3	Univ of North Carolina Hosps	Chapel Hill	North Carolina	United States	27599
4	Carolinas Med Ctr	Charlotte	North Carolina	United States	28232
5	Infectious Diseases Physicians Inc	Annandale	Virginia	United States	22003
6	Univ of Wisconsin School of Medicine	Madison	Wisconsin	United States	53792
7	San Juan AIDS Program	Santurce		Puerto Rico	00907