Los Angeles, California 90027

  • HIV Infections

Purpose:

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.


Criteria:

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.


Study is Available At:


Original ID:

298C


NCT ID:

NCT00006208


Secondary ID:

FTC-301


Study Acronym:


Brief Title:

A Comparison of Emtricitabine and Stavudine Used With Didanosine Plus Efavirenz in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs


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


Overall Status:

Active, not recruiting


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Masking:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Start Date:August 2000
Verification Date:June 2006
Last Changed Date:June 23, 2005
First Received Date:September 11, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Efavirenz
Intervention Type:Drug
Name:Emtricitabine
Intervention Type:Drug
Name:Stavudine
Intervention Type:Drug
Name:Didanosine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Triangle Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


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