Completed

Viramune and Lamivudine (3TC) Combination for Preventing Clinical AIDS Progression

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What is being tested

Nevirapine

+ Lamivudine

Drug
Who is being recruted

Blood-Borne Infections+17

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorBoehringer Ingelheim
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Eligible patients will be randomized to treatment with either 1) open-label 3TC twice daily plus Viramune once daily for 2 weeks and then with Viramune twice daily; or 2) open label 3TC twice daily plus Viramune placebo once daily for 2 weeks and then twice daily Viramune. Patients will start Viramune and 3TC on study day 0. Patients will be evaluated for development of AIDS progression events at months 1, 2, 3, and 4, and every 2 months thereafter until 18 months after the last patient is enrolled or 24 months, whichever occurs first.

NCT00002368
Principal SponsorBoehringer Ingelheim
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsPathologic ProcessesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesPathological Conditions, Signs and SymptomsVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsDisease AttributesAcquired Immunodeficiency SyndromeHIV InfectionsDisease Progression

Criteria

5 inclusion criteria required to participate
CD4+ cell count <= 200 cells/mm3
Documented HIV infection
Life expectancy > 3 months
Willingness and ability to follow protocol requirements
Show More Criteria
15 exclusion criteria prevent from participating
Cimetidine
Dicumarol, Warfarin and other anticoagulant medications
Erythromycin
History of clinically important disease other than HIV-1 infection or related diseases that, in the opinion of the investigator, may put the patient at risk because of participation in this study
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 53 locations

Drug Research and Analysis Corp

Montgomery, United StatesOpen Drug Research and Analysis Corp in Google Maps

Dr G Michael Wool

Los Angeles, United States

UCLA School of Medicine / Ctr for Research and Education

Los Angeles, United States

AIDS Research Ctr / Palo Alto VA Health Care System

Palo Alto, United States
Completed53 Study Centers