Overview

This trial is active, not recruiting.

Condition hiv infections
Treatments efavirenz, emtricitabine, stavudine, didanosine
Phase phase 3
Sponsor Triangle Pharmaceuticals
Start date August 2000
Trial identifier NCT00006208, 298C, FTC-301

Summary

The purpose of this study is to compare the safety and effectiveness of emtricitabine and stavudine when given with didanosine plus efavirenz to HIV-infected patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Masking double-blind
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria Patients may be eligible for this study if they: - Are at least 18 years old at the time of screening. - Have plasma HIV-1 RNA loads (level of HIV in your blood) of 5,000 or more copies/ml at the time of screening. - Have not used any anti-HIV therapy for more than 2 days. - Have a negative pregnancy test within 22 days of starting study drugs. - Can be reached by telephone. Exclusion Criteria Patients will not be eligible for this study if they: - Are pregnant or breast-feeding. - Use alcohol or illegal drugs that, in the opinion of the principal investigator, may interfere with the patient's ability to follow the dosing schedule and protocol evaluations. - Are being treated for active tuberculosis. - Are using astemizole, cisapride, midazolam, triazolam, ergot derivatives, St. John's wort, or drugs for a mental disorder. - Have a history of a serious mental disorder. - Are unwilling to use an effective barrier method of birth control during the study (for women who can get pregnant). - Have a history of opportunistic infections and cancers (Mycobacterium avium complex, cytomegalovirus, toxoplasmic encephalitis or disseminated toxoplasmosis, cryptosporidiosis, Isospora belli, progressive multifocal leukoencephalopathy, visceral Kaposi's sarcoma, and lymphoma). Patients with past episode of pulmonary tuberculosis, Pneumocystis carinii pneumonia, or isolated cutaneous Kaposi's sarcoma are allowed. Medication for the prevention of PCP (TMP/SMX, nebulized pentamidine, and atovaquone) is allowed. - Have peripheral neuropathy (a painful condition affecting the nervous system) or history of peripheral neuropathy. - Cannot take medicine by mouth or have severe chronic diarrhea within 30 days before beginning the study. - Cannot eat 1 or more meals a day because of chronic nausea, vomiting, or abdominal or esophageal discomfort. - Have had a serious illness or injury within 30 days of screening. Treatment must have been completed for 14 days prior to study entry. - Have a history of AIDS-defining opportunistic infection, except for tuberculosis or infection of the stomach or intestines.

Additional Information

Official title A Randomized, Double-Blind, Equivalence Trial Comparing Emtricitabine to Stavudine Within a Triple Drug Combination Containing Didanosine Plus Efavirenz in Antiretroviral-Drug Naive HIV-1 Infected Patients
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by NIH AIDS Clinical Trials Information Service.