Study of Treatment of Antiretroviral-naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavirenz.
This study is ongoing, but not recruiting participants.
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00158821
First received: September 7, 2005
Last updated: June 12, 2012
Last verified: June 2012
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Purpose
To compare tenofovir DF plus lamivudine plus efavirenz vs. stavudine plus lamivudine plus efavirenz in the treatment of HIV-1-infected patients who have never taken antiretroviral drugs and have a viral load of less than 400 copies/mL at week 48.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Viread (tenofovir disoproxil fumarate) Drug: Sustiva (Efavirenz) Drug: Epivir (Lamivudine) Drug: Zerit (Stavudine) Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3, Randomized, Double-Blind, Multicenter Study of the Treatment of Antiretroviral-naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavirenz.(Extension) |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Formic acid
Stavudine
Lamivudine
Tenofovir
Efavirenz
Tenofovir Disoproxil Fumarate
U.S. FDA Resources
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- To compare the two treatment groups with the goal of achieving HIV-1 RNA levels less than 50 copies/mL at week 48. [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]compare the two treatment groups with the goal of achieving HIV-1 RNA levels
- To compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure. [ Time Frame: 144 Weeks ] [ Designated as safety issue: Yes ]compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure
Secondary Outcome Measures:
- To evaluate the long-term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 336 weeks of drug exposure. [ Time Frame: 336 Weeks ] [ Designated as safety issue: Yes ]evaluate the long-term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 336 weeks of drug exposure
- To evaluate the long term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 480 weeks of drug exposure. [ Time Frame: 480 Weeks ] [ Designated as safety issue: Yes ]evaluate the long term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 480 weeks of drug exposure.
- To evaluate the long term efficacy, safety and tolerability of tenofovir DF through approximately 624 weeks of drug exposure. [ Time Frame: 624 Weeks ] [ Designated as safety issue: Yes ]evaluate the long term efficacy, safety and tolerability of tenofovir DF through approximately 624 weeks of drug exposure
| Estimated Enrollment: | 180 |
| Study Start Date: | March 2000 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Viread (tenofovir disoproxil fumarate)
Tenofovir DF 300 mg tablets once daily
Other Name: Viread
Drug: Sustiva (Efavirenz)
efavirenz capsules 600 mg once daily
Other Name: Sustiva
Drug: Epivir (Lamivudine)
lamivudine 150 mg tablets twice daily
Other Name: Epivir
Drug: Zerit (Stavudine) Placebo
stavudine placebo capsules twice daily
Other Name: Zerit
To compare the two treatment groups with the goal of achieving HIV-1 RNA levels less than 50 copies/mL at week 48.
To compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure.
To evaluate the long-term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 336 weeks of drug exposure.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Completed the original 96-weeks of open-label treatment. Willingness to use effective contraception by both males and females while on study treatment and for 30 days following study drugs completion. The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures related to the second 96-week open-label phase extension.
Exclusion Criteria:
- Patients requiring therapy with any of the following: Nephrotoxic agents (aminoglycoside antibiotics, IV amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, oral and IV vancomycin, oral and IV ganciclovir, other agents with significant nephrotoxic potential);Probenecid; Systemic chemotherapeutic agents; Systemic corticosteroids; Interleukin-2 (IL-2); Investigational agents (except on approval by Gilead Sciences); Drugs that interact with efavirenz (astemizole, terfenadine, dihydroergotamine, ergotamine, midazolam, triazolam, cisapride, rifampin, ergonovine, methylergonovine, voriconazole). Administration of any of the listed medications is not allowed throughout the duration of the study period.
- Pregnant or lactating patients.
- Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication.
- Current alcohol or substance abuse judged by the investigator to potentially interfere with patient compliance.
- Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Patients with biopsy-confirmed cutaneous KS are eligible, if they are not anticipated to require systemic therapy during the study.
- Active, serious infections(other than HIV-1 infection) requiring parenteral antibiotic therapy.
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements.
Contacts and Locations More Information
Additional Information:
No publications provided by Gilead Sciences
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00158821 History of Changes |
| Obsolete Identifiers: | NCT00005573 |
| Other Study ID Numbers: | GS-99-903 |
| Study First Received: | September 7, 2005 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
HIV Antiretroviral Treatment Experienced HIV-1 |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Stavudine Lamivudine Tenofovir |
Tenofovir disoproxil Efavirenz Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on June 18, 2013