Completed

MKC-442 and Nelfinavir for HIV-1 RNA Reduction in Experienced Patients

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What is being tested

Emivirine

+ Nelfinavir mesylate

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+39 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

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

In this randomized, placebo-controlled study, patients are allowed to switch at entry to d4T plus 3TC or d4T plus ddI based on investigator and patient preference. Patients are stratified based on the number of nucleoside reverse transcriptase inhibitor (NRTI) treatments that are changed at entry and on screening HIV-1 RNA (obtained within 30 days of entry) as follows: switched 1 NRTI and 10,000-50,000 copies/ml vs switched 1 NRTI and greater than 50,000 copies/ml vs switched 2 NRTIs and 10,000-50,000 copies/ml vs switched 2 NRTIs and greater than 50,000 copies/ml. Patients are randomized within each of these strata to 1 of the following treatment arms: Arm 1: MKC-442 placebo plus nelfinavir. Arm 2: MKC-442 plus nelfinavir. Arm 3: MKC-442 plus nelfinavir (higher dose). Treatment is administered for 48 weeks. Patients who are considered virologic successes at Week 48 may continue to receive MKC-442 at the discretion of the investigator.

NCT00002215
Principal SponsorTriangle Pharmaceuticals
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.

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 18 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 DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

20 inclusion criteria required to participate
* Allowed only with caution and close patient monitoring
* Chemoprophylaxis for Pneumocystis carinii pneumonia
* HIV-1 RNA greater than 10,000
* Ketoconazole, fluconazole, itraconazole, and grapefruit juice
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19 exclusion criteria prevent from participating
Active AIDS-defining illnesses
Amiodarone, quinidine, astemizole, terfenadine, ergot derivatives, midazolam, triazolam, and cisapride
Any intercurrent illness that could affect viral load determination [AS PER AMENDMENT 8/4/98]
Current alcohol or illicit drug use that, in the opinion of the investigator, may interfere with ability of patient to comply with dosing schedule and protocol evaluations
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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 1 location

Anderson Clinical Research

Pittsburgh, United StatesOpen Anderson Clinical Research in Google Maps
CompletedOne Study Center