HIV InfectionsPhase 3NCT00158821
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.
A Phase 3 study testing Viread (tenofovir disoproxil fumarate), Sustiva (Efavirenz) and Epivir (Lamivudine) in people with HIV Infections, run by Gilead Sciences.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Viread (tenofovir disoproxil fumarate), Sustiva (Efavirenz) and Epivir (Lamivudine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Mar 2000to Jun 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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)
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.
Read the detailed description
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.
- Conditions
- HIV Infections
- Being tested
- Viread (tenofovir disoproxil fumarate), Sustiva (Efavirenz), Epivir (Lamivudine), Zerit (Stavudine) Placebo
- Keywords
- HIV, Antiretroviral, Treatment Experienced, HIV-1
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viread (tenofovir disoproxil fumarate)Drug
Also called Viread
Tenofovir DF 300 mg tablets once daily
Sustiva (Efavirenz)Drug
Also called Sustiva
efavirenz capsules 600 mg once daily
Epivir (Lamivudine)Drug
Also called Epivir
lamivudine 150 mg tablets twice daily
Zerit (Stavudine) PlaceboDrug
Also called Zerit
stavudine placebo capsules twice daily
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the two treatment groups with the goal of achieving HIV-1 RNA levels less than 50 copies/mL at week 48.
compare the two treatment groups with the goal of achieving HIV-1 RNA levels
Measured: Week 48
To compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure.
compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure
Measured: 144 Weeks
Secondary outcomes (3)
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.
evaluate the long-term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 336 weeks of drug exposure
Measured: 336 Weeks
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.
evaluate the long term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 480 weeks of drug exposure.
Measured: 480 Weeks
To evaluate the long term efficacy, safety and tolerability of tenofovir DF through approximately 624 weeks of drug exposure.
evaluate the long term efficacy, safety and tolerability of tenofovir DF through approximately 624 weeks of drug exposure
Measured: 624 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2000
- Primary completionDec 2001
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erin Quirk, M.D., Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158821
- Sponsor's protocol ID
- GS-99-903
- Status last verified
- Jun 2013
- First submitted
- 7 Sep 2005
- Last updated
- 25 Jun 2013
- Results posted
- No
Publications
Madruga JR, Cassetti I, Suleiman JM, Etzel A, Zhong L, Holmes CB, Cheng AK, Enejosa J; Study 903E Team. The safety and efficacy of switching stavudine to tenofovir df in combination with lamivudine and efavirenz in hiv-1-infected patients: three-year follow-up after switching therapy. HIV Clin Trials. 2007 Nov-Dec;8(6):381-90. doi: 10.1310/hct0806-381.
PubMed 18042503
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00158821
- Acronym / sponsor ID
- GS-99-903
- Conditions
- HIV Infections
- Keywords
- HIV, Antiretroviral, Treatment Experienced, HIV-1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Mar 2000
- Primary completion
- Dec 2001 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viread (tenofovir disoproxil fumarate)Also: VireadTenofovir DF 300 mg tablets once daily | Drug | – |
| Sustiva (Efavirenz)Also: Sustivaefavirenz capsules 600 mg once daily | Drug | – |
| Epivir (Lamivudine)Also: Epivirlamivudine 150 mg tablets twice daily | Drug | – |
| Zerit (Stavudine) PlaceboAlso: Zeritstavudine placebo capsules twice daily | Drug | – |
Primary outcome
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
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
compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure
3 secondary outcomes
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
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
To evaluate the long term efficacy, safety and tolerability of tenofovir DF through approximately 624 weeks of drug exposure.
Time frame: 624 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2013.
- Derived from this study: PubMed 18042503Madruga JR, Cassetti I, Suleiman JM, Etzel A, Zhong L, Holmes CB, Cheng AK, Enejosa J; Study 903E Team. The safety and efficacy of switching stavudine to tenofovir df in combination with lamivudine and efavirenz in hiv-1-infected patients: three-year follow-up after switching therapy. HIV Clin Trials. 2007 Nov-Dec;8(6):381-90. doi: 10.1310/hct0806-381.
- Gilead websiteLink provided by the sponsor.
- Study ResultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Quirk, M.D. study director
Gilead Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Viread (tenofovir disoproxil fumarate), Sustiva (Efavirenz) and Epivir (Lamivudine) in people with HIV Infections, run by Gilead Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00158821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2013.