Completed

Capravirine, Nelfinavir Mesylate, and NRTIs Combination for HIV-Infected Patients Failing Initial Nonnucleoside Reverse Transcriptase Inhibitor Regimen

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What is being tested

Capravirine

+ Nelfinavir mesylate

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2000
See protocol details

Summary

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

Study start date: January 1, 2000

Actual date on which the first participant was enrolled.

[Note: As of 2/28/2001, due to toxicity studies and concern for safety, changes in the methodology were implemented and patients need to sign new informed consents. The study is unblinded. Group 1 receives AG1549; Group 2 receives an AG1549 placebo. Patients who are taking capravirine and who currently have viral loads below 400 copies/ml may continue to take capravirine at 1400 mg twice daily. Capravirine will be discontinued in patients with viral loads greater than 400 copies/ml at their last visit and they will be switched to new therapies or continue with their background therapies as deemed appropriate by the investigators.] Both groups also receive nelfinavir mesylate and 2 NRTIs. All patients receive the same dose of nelfinavir mesylate. The NRTIs are selected at the investigator's discretion provided the patient has not previously received the chosen NRTIs. Patients have regular physical examinations. Blood samples are collected regularly and at 1 month post-treatment to determine plasma HIV RNA, pharmacokinetics, and CD4 and CD8 counts. Patients who complete 24 weeks of treatment will have the option to continue treatment for an additional 24 weeks or end participation.

NCT00004985
Principal SponsorAgouron 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.
Design Details

75 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 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

5 inclusion criteria required to participate
Are HIV-positive

Are at least 18 years old

Are currently taking an anti-HIV drug combination of an NNRTI plus 1 or more NRTIs for more than 28 days and are failing that combination

Have a CD4 cell count more than 50/mm3

Show More Criteria

3 exclusion criteria prevent from participating
Have been given any drug that interferes with their immune system or with the study drugs within 28 days of study entry

Have had any protease inhibitor or capravirine treatment

Have had radiation therapy within 28 days of study entry

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 34 locations

Phoenix Body Positive

Phoenix, United StatesOpen Phoenix Body Positive in Google Maps

Pacific Oaks Med Group

Beverly Hills, United States

First Choice Medical

Palm Springs, United States

Apogee Med Group

San Diego, United States
Completed34 Study Centers