HIV InfectionsPhase 3NCT00669487
A 72-week Randomized Clinical Trial Comparing the Safety and Efficacy of Three Initial Antiretroviral Regimens -GPO-VIR S (d4T/3TC/NVP) for 24 Weeks Followed by GPO-VIR Z (AZT/3TC/NVP) vs GPO-VIR Z vs TDF/FTC/NVP
A Phase 3 study testing AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP in people with HIV Infections, run by SEARCH Research Foundation at 1 site in Thailand.
Trial summary
This protocol aims to determine the risk/benefits of this policy by comparing head-to-head a regimen of GPO-VIR Z or TDF/FTC/NVP for 18 months in ARV-naïve patients to a 6-month lead in with GPO-VIR S followed by 12 months of GPO-VIR Z. 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?
- AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2008to Apr 2011
- 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
- Documented HIV-1 infection
- Age ≥ 18 years old.
- Subjects must be naïve to ARV. Individuals with past exposure to ARV associated with pregnancy will be allowed to enroll as long as the exposure is at least 3 months prior to entry.
- CD4 < 350 cells/mm3
- Subject understands the study and is able to sign informed consent
Who cannot join
- Evidence of symptomatic persistent symptoms of tingling or numbness of lower extremities and bilateral lower extremity neuropathy on exam at entry. Abnormal exam includes 1) Diminished (compared with the knee) or absent ankle reflexes OR 2) Diminution of either vibration sensation in the legs (defined as perception of vibration for < 10 seconds at the great toe with a tuning fork initially struck hard enough to be audible) OR 3) Diminution of pin or temperature sensation in lower extremities OR 4) Contact allodynia in the feet.
- Laboratory values 1) Absolute neutrophil count (ANC) < 750/mm3 2) Hemoglobin < 8.0 g/dL 3) ALT (SGPT) > 5 x ULN 4) Creatinine > 2 X ULN or < creatinine clearance < 30 cc per min by Cockroft-Gault formula
- Active AIDS-defining opportunistic infection (OI) within 30 days prior to entry. Subjects must be off all acute treatments for OI for at least 14 days prior to entry. Subjects on maintenance or prophylactic therapy for AIDS-related OIs will be eligible.
- Any immunomodulator, HIV vaccine or investigational therapy within 30 days of study entry
- Pregnancy or breast-feeding; intent to become pregnant during the course of the study.
- Presence of any active malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
This protocol aims to determine the risk/benefits of this policy by comparing head-to-head a regimen of GPO-VIR Z or TDF/FTC/NVP for 18 months in ARV-naïve patients to a 6-month lead in with GPO-VIR S followed by 12 months of GPO-VIR Z. The primary outcomes to be assessed will be anemia, neuropathy, lipoatrophy and renal function.
Read the detailed description
GPO-VIR Z is a new combination antiretroviral (ARV) medication that substitutes zidovudine (AZT) for stavudine (d4T) from the original formulation of GPO-VIR S. This new combination should decrease rates of lipoatrophy and neuropathy which are side-effects strongly linked to the use of d4T. However, there is some risk that initiating therapy with an AZT- containing regimen may cause unacceptable rates of anemia. Many Thai physicians have adopted a practice of using 6 months of the stavudine-containing GPO-VIR S as a lead in before introducing AZT-containing GPO-VIR Z in an effort to balance the risks and benefits of these two medications. There are no definitive data, however, that can attest to the benefit of such an approach.
- Conditions
- HIV Infections
- Being tested
- AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP
- Keywords
- HIV/AIDS patients
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVPDrug
Truvada(FTC200mg+TDF300mg) every 24 hours + NVP 200 mg every 12 hours orally until week 72
AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVPDrug
GPO-VIR S(D4T30mg+3TC150mg+NVP200mg)1 pill orally every 12 hours until week 24 and then switch to GPO-VIR Z
AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVPDrug
GPO-VIR Z(AZT250mg+3TC150mg+NVP200mg) 1 pill orally every 12 hours until week 72
| Study group | Role | What they receive |
|---|---|---|
| 1. GPO-VIR S 1 pill orally every 12 hours | Experimental | Not described Receives: Drug: AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP |
| 2 GPO-VIR Z 1 pill orally every 12 hours | Experimental | Not described Receives: Drug: AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP |
| 3 Truvada 1 pill oral q 24 hr and NVP 1 pill oral q 12 hr | Experimental | Not described Receives: Drug: AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean hemoglobin at 24 weeks and 72 weeks
Measured: 72 weeks
Proportion of participants with peripheral neuropathy at 24 weeks and 72 weeks
Measured: 72 weeks
Secondary outcomes (4)
Changes from baseline in body weight, limb fat, and lean body mass by DEXA scan at 24 weeks and 72 weeks
Measured: 72 weeks
Change from baseline in serum creatinine at 24 weeks and 72 weeks
Measured: 72 weeks
Proportion of participants with plasma HIV-1 RNA less than 50 copies/mL at 24 weeks and 72 weeks
Measured: 72 weeks
Change from baseline in CD4 count at 24 weeks and 72 weeks
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEARCH Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Savang Vadhana Memorial Hospital, Thailand, Thai Red Cross AIDS Research Centre, University of Hawaii
- Responsible party
- Principal investigator, Assoc.Prof.Jintanat Ananworanich, M.D., SEARCH Research Foundation
- Investigators
- Jintanat - Ananworanich, M.D., Principal investigator, SEARCH ThailandJintanat - Ananworanich, M.D., Ph.D, Principal investigator, SEARCH Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669487
- Sponsor's protocol ID
- SEARCH003
- Status last verified
- May 2015
- First submitted
- 24 Apr 2008
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 72-week Randomized Clinical Trial Comparing the Safety and Efficacy of Three Initial Antiretroviral Regimens -GPO-VIR S (d4T/3TC/NVP) for 24 Weeks Followed by GPO-VIR Z (AZT/3TC/NVP) vs GPO-VIR Z vs TDF/FTC/NVP
- ClinicalTrials.gov ID
- NCT00669487
- Acronym / sponsor ID
- SEARCH003
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- SEARCH Research FoundationUniversity, hospital or other
- Collaborators
- Queen Savang Vadhana Memorial Hospital, Thailand, Thai Red Cross AIDS Research Centre, University of Hawaii
- Study start
- Apr 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 30 Apr 2008 (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.
This protocol aims to determine the risk/benefits of this policy by comparing head-to-head a regimen of GPO-VIR Z or TDF/FTC/NVP for 18 months in ARV-naïve patients to a 6-month lead in with GPO-VIR S followed by 12 months of GPO-VIR Z. The primary outcomes to be assessed will be anemia, neuropathy, lipoatrophy and renal function.
Detailed description
GPO-VIR Z is a new combination antiretroviral (ARV) medication that substitutes zidovudine (AZT) for stavudine (d4T) from the original formulation of GPO-VIR S. This new combination should decrease rates of lipoatrophy and neuropathy which are side-effects strongly linked to the use of d4T. However, there is some risk that initiating therapy with an AZT- containing regimen may cause unacceptable rates of anemia. Many Thai physicians have adopted a practice of using 6 months of the stavudine-containing GPO-VIR S as a lead in before introducing AZT-containing GPO-VIR Z in an effort to balance the risks and benefits of these two medications. There are no definitive data, however, that can attest to the benefit of such an approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. GPO-VIR S 1 pill orally every 12 hours | Experimental | Drug: AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP |
| 2 GPO-VIR Z 1 pill orally every 12 hours | Experimental | Drug: AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP |
| 3 Truvada 1 pill oral q 24 hr and NVP 1 pill oral q 12 hr | Experimental | Drug: AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented HIV-1 infection
- Age ≥ 18 years old.
- Subjects must be naïve to ARV. Individuals with past exposure to ARV associated with pregnancy will be allowed to enroll as long as the exposure is at least 3 months prior to entry.
- CD4 < 350 cells/mm3
- Subject understands the study and is able to sign informed consent
Key exclusion criteria (6 listed)
- Evidence of symptomatic persistent symptoms of tingling or numbness of lower extremities and bilateral lower extremity neuropathy on exam at entry. Abnormal exam includes 1) Diminished (compared with the knee) or absent ankle reflexes OR 2) Diminution of either vibration sensation in the legs (defined as perception of vibration for < 10 seconds at the great toe with a tuning fork initially struck hard enough to be audible) OR 3) Diminution of pin or temperature sensation in lower extremities OR 4) Contact allodynia in the feet.
- Laboratory values 1) Absolute neutrophil count (ANC) < 750/mm3 2) Hemoglobin < 8.0 g/dL 3) ALT (SGPT) > 5 x ULN 4) Creatinine > 2 X ULN or < creatinine clearance < 30 cc per min by Cockroft-Gault formula
- Active AIDS-defining opportunistic infection (OI) within 30 days prior to entry. Subjects must be off all acute treatments for OI for at least 14 days prior to entry. Subjects on maintenance or prophylactic therapy for AIDS-related OIs will be eligible.
- Any immunomodulator, HIV vaccine or investigational therapy within 30 days of study entry
- Pregnancy or breast-feeding; intent to become pregnant during the course of 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 |
|---|---|---|
| AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVPTruvada(FTC200mg+TDF300mg) every 24 hours + NVP 200 mg every 12 hours orally until week 72 | Drug | 3 Truvada 1 pill oral q 24 hr and NVP 1 pill oral q 12 hr |
| AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVPGPO-VIR S(D4T30mg+3TC150mg+NVP200mg)1 pill orally every 12 hours until week 24 and then switch to GPO-VIR Z | Drug | 1. GPO-VIR S 1 pill orally every 12 hours, 2 GPO-VIR Z 1 pill orally every 12 hours, 3 Truvada 1 pill oral q 24 hr and NVP 1 pill oral q 12 hr |
| AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVPGPO-VIR Z(AZT250mg+3TC150mg+NVP200mg) 1 pill orally every 12 hours until week 72 | Drug | 1. GPO-VIR S 1 pill orally every 12 hours, 2 GPO-VIR Z 1 pill orally every 12 hours, 3 Truvada 1 pill oral q 24 hr and NVP 1 pill oral q 12 hr |
Primary outcome
Change from baseline in mean hemoglobin at 24 weeks and 72 weeks
Time frame: 72 weeks
Proportion of participants with peripheral neuropathy at 24 weeks and 72 weeks
Time frame: 72 weeks
4 secondary outcomes
Changes from baseline in body weight, limb fat, and lean body mass by DEXA scan at 24 weeks and 72 weeks
Time frame: 72 weeks
Change from baseline in serum creatinine at 24 weeks and 72 weeks
Time frame: 72 weeks
Proportion of participants with plasma HIV-1 RNA less than 50 copies/mL at 24 weeks and 72 weeks
Time frame: 72 weeks
Change from baseline in CD4 count at 24 weeks and 72 weeks
Time frame: 72 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 28 May 2015.
Related trials for HIV Infections
RecruitingPhase 2
Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption
HIV
Recruiting
Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
HIV (Human Immunodeficiency Virus), HPV
Not yet recruiting
Combating HIV Stigma in Healthcare Settings: A Standardized Patient Approach
Hiv
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS7 Zimbabwe
HIV (Human Immunodeficiency Virus), HPV
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.
Jintanat - Ananworanich, M.D. principal investigator
SEARCH Thailand
Jintanat - Ananworanich, M.D., Ph.D principal investigator
SEARCH Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP in people with HIV Infections, run by SEARCH Research Foundation at 1 site in Thailand.
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 5 inclusion and 6 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 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change from baseline in mean hemoglobin at 24 weeks and 72 weeks (time frame: 72 weeks). 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?
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 28 May 2015.