The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00002418
• Other study ID #: 292D
• Secondary ID: ICC 601
• Status: Terminated
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: August 13, 2008

Study information

• Verified date: March 2000
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) and who have failed to respond to protease inhibitors (PIs). The drug combination will contain didanosine (ddI) plus stavudine (d4T) plus nevirapine (NVP) plus MKC-442. Hydroxyurea (HU) may be added.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Emivirine

• Hydroxyurea

• Nevirapine

• Stavudine

• Didanosine

Locations

Country	Name	City	State
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Pacific Oaks Med Group	Beverly Hills	California
United States	Univ of Colorado / Health Science Ctr	Denver	Colorado
United States	Hampton Roads Med Specialists	Hampton	Virginia
United States	Brown Univ School of Medicine	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Boehringer Ingelheim, Triangle Pharmaceuticals

Country where clinical trial is conducted

United States,