Suspended

A Phase II, 24-Week, Open-Label Study Designed to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Novel Combination Therapy With Videx (Didanosine), Zerit (Stavudine), Viramune (Nevirapine), and MKC-442 (With or Without Hydroxyurea) for the Treatment of HIV-1 Infection in Non-Nucleoside Reverse Transcriptase Inhibitor Naive Patients Who Failed Previous Protease Inhibitor Treatment

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Emivirine

+ Hydroxyurea

+ Nevirapine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorBristol-Myers Squibb
Last updated: August 14, 2008
Sourced from a government-validated database.Claim as a partner

Patients receive a regimen of didanosine, stavudine, nevirapine, and MKC-442 for 24 weeks. Throughout the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. Patients who experience virologic failure have the option of adding hydroxyurea to their treatment regimen or discontinuing from the study. After Week 24, patients with documented virologic response may continue treatment with didanosine, stavudine, nevirapine, and MKC-442, and, if applicable, hydroxyurea until a change in virologic status occurs (i.e., the patient experiences virologic failure). Follow-up visits are conducted every 4 to 12 weeks until permanent discontinuation from the study.

Principal SponsorBristol-Myers Squibb
Last updated: August 14, 2008
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

25 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

Inclusion Criteria You may be eligible for this study if you: Are at least 18 years old. Are HIV-positive. Have experienced treatment failure on a previous anti-HIV drug combination that contained at least one protease inhibitor. Your viral load must be between 5,000 and 50,000 copies/ml after 6 months of continuous treatment with that drug combination. Agree to use a barrier method of birth control (such as condoms) during the study. Exclusion Criteria You will not be eligible for this study if you: Have a history of certain serious medical conditions, including pancreatitis, neuropathy, untreated seizures, or AIDS-related cancers, except Kaposi's sarcoma (KS). Are enrolled in another anti-HIV drug study while participating in this study. Have ever taken NNRTIs (such as NVP or MKC-442). Have ever taken ddI or d4T. Have taken certain medications within 30 days prior to study entry, including medications that affect your immune system (such as corticosteroids, interleukin-2, or interferon). Abuse alcohol or drugs. Have received chemotherapy or radiation therapy within 30 days prior to study entry. (Local radiation therapy is allowed.) Are allergic to any of the study drugs. Are pregnant or breast-feeding.

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 5 locations

Pacific Oaks Med Group

Beverly Hills, United StatesOpen Pacific Oaks Med Group in Google Maps

Univ of Colorado / Health Science Ctr

Denver, United States

AIDS Research Consortium of Atlanta

Atlanta, United States

Brown Univ School of Medicine

Providence, United States
Suspended5 Study Centers