TuberculosisPhase 3NCT00332306
Safety and Efficacy of Two Once Daily Anti Retroviral Treatment Regimens Along With Anti-tuberculosis Treatment
A Phase 3 study testing Didanosine, Lamivudine, Efavirenz and Didanosine, Lamivudine, Nevirapine in people with Tuberculosis and Human Immunodeficiency Virus Infections, run by Tuberculosis Research Centre, India at 1 site in India.
Trial summary
Protocol Summary Title: Evaluation of safety and efficacy of two different once daily anti-retroviral treatment regimens along with anti-tuberculosis treatment in patients with HIV-1 and tuberculosis - Randomized Controlled Clinical Trial Phase: Phase III trial Population: 180 HIV-1 positive patients with tuberculosis… Read more about this study
- Who is it for?
- Ages 18 to 61 years
- Conditions the study is for
- Tuberculosis, Human Immunodeficiency Virus Infections
- What is being tested?
- Didanosine, Lamivudine, Efavirenz and Didanosine, Lamivudine, Nevirapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2006to Dec 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 to 61 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age > 18 years
- a) Newly diagnosed sputum smear positive tuberculosis (at least 1 out of 6 sputum specimen should be positive by smear) b)Miliary tuberculosis, mediastinal/hilar lymphadenopathy, diagnosed by chest radiography or CT scan (irrespective of sputum smear status).
- c)TB lymphadenitis with histopathological/bacteriological evidence of TB d)Pleural effusion with biochemical/cytological/bacteriological evidence of TB
- HIV-1 positivity (on 2 different rapid tests on the same blood sample)
- CD4 cell counts less than 250 cells/mm3
- Likely to remain in the same area for at least two years after start of treatment.
Show all 10Show fewer
- Willingness to stay in the hospital for 2 weeks during initiation of ART, and attend the clinic thrice weekly for the entire period of the study (up to 2 years).
- Willingness for home visits, and to attend for investigations, supervised treatment and follow-up as required.
- Within the area of intake (25 kms from any of the TRC subcentres).
- Willingness to use contraception during trial period.
Who cannot join
- Resides outside area of intake.
- Pregnancy and lactation.
- Patients with major psychiatric illnesses and severe depression
- Major complications of HIV disease like encephalopathy, renal (Serum creatinine level > 1.2 mgs/dl) or hepatic disease (Serum bilirubin > 2.0 times upper limit of normal, Serum transaminases > 2.5 times upper limit of normal), serum amylase > 2 times upper limit of normal with serum lipase > 1.5 times upper limit of normal.
- Serious cardiac disease (CCF, IHD), uncontrolled diabetes mellitus, cancer, moribund state
- Previous antituberculosis treatment for more than 1 month.
Show all 12Show fewer
- Previous antiretroviral treatment for more than 1 month
- Patients with CD4 cell count >250 cells/mm3.
- HIV-2 infection alone or in combination with HIV-1.
- Patients currently using alcohol, IV drugs \& other substance abuse.
- Unwilling to use contraception \& avoid pregnancy.
- Unwilling to HIV/TB screening and participation in trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Safety and Efficacy of Two Different Once Daily Anti Retroviral Treatment Regimens Along With Anti-tuberculosis Treatment in Patients With HIV-1 and Tuberculosis
Protocol Summary
Title: Evaluation of safety and efficacy of two different once daily anti-retroviral treatment regimens along with anti-tuberculosis treatment in patients with HIV-1 and tuberculosis - Randomized Controlled Clinical Trial
Read more
Phase: Phase III trial
Population: 180 HIV-1 positive patients with tuberculosis
Number of Sites: Four.
- Tuberculosis Research Centre, Chennai
- Government Medical College, Vellore
- Government Hospital of Thoracic Medicine, Tambaram
- Government Rajaji Hospital, Madurai
Study Duration: 26 months including 24 months of ART.
Study Objectives:
Primary Objective To compare the efficacy and safety of two different once-daily anti-retroviral treatment regimens (along with standard anti-tuberculosis treatment) in patients with HIV-1 and tuberculosis, by using virologic end points.
Secondary Objective To compare the efficacy of antiretroviral treatment given under partial supervision with unsupervised treatment (once a month supply).
Read the detailed description
Description of Agent or Intervention:
The study intervention is to start patients with HIV and tuberculosis on anti-retroviral treatment along with the continuation phase of anti-tuberculosis treatment (ATT)ie after completion of first two months of treatment. The anti-TB regimen used in this trial will be 2EHRZ3/4RH3. Two different once-daily regimens are being compared for their efficacy and adverse event profile, namely ddI + 3TC + NVP versus ddI + 3TC + EFZ. The primary aim is to study the outcome of patients treated with both ART and ATT at 6 months (24 weeks of ART). A secondary objective is to compare the utility of partially supervised directly observed treatment with unsupervised administration of anti-retroviral drugs.
Patients with HIV-1 infection and active tuberculosis (pulmonary and extrapulmonary) will be started on a four-drug intermittent short-course anti-TB regimen on recruitment to the trial. They will be randomized at the end of intensive phase of ATT to receive either of the ART regimens and the outcome measured at the end of 6 months. During this phase, both ATT and ART will be given under supervision three times a week. Patients with viral load < 400 copies/ml(favourable outcome) at this time point will be randomized to receive ART either by partial observation of treatment (three times a week)or monthly supply (unsupervised administration) and final outcome will be measured at the end of 24 months of ART. The study will provide information on the comparative efficacy of the two regimens when given with anti-TB treatment as well as any added advantage that direct observation of treatment may provide.
- Being tested
- Didanosine, Lamivudine, Efavirenz, Didanosine, Lamivudine, Nevirapine
- Keywords
- Once daily antiretroviral treatment, Concomitant antituberculosis treatment, HIV Infections
- Medical subject headings
- Tuberculosis, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Didanosine, Lamivudine, EfavirenzDrug
Didanosine 250mg patients <60kg, 400mg patients > 60kg once daily Lamivudine 300 mg once daily Efavirenz 600 mg once daily All drugs will be given for 24 months
Didanosine, Lamivudine, NevirapineDrug
Didanosine 250 mg once daily for patients < 60kg, 400 mg OD patients > 60kg Lamivudine 300 mg once daily Nevirapine 400 mg once daily All drugs will be given for 24 months
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Didanosine + Lamivudine + Nevirapine Receives: Drug: Didanosine, Lamivudine, Nevirapine |
| 1 | Active comparator | Didanosine + Lamivudine + Efavirenz Receives: Drug: Didanosine, Lamivudine, Efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suppression of Viral load to < 400 copies/ml or a two log reduction in viral load from the baseline value at the end of 6 months and a viral load <400 copies/ml at 24 months of antiretroviral therapy
Measured: Dec 2008
Secondary outcomes (2)
To compare the response to treatment between partially supervised drug administration and unsupervised drug administration.
Measured: Dec 2009
To compare the tolerability and toxicity attributable to study drugs.
Measured: Dec 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2009 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tuberculosis Research Centre, India
- Sponsor type
- Other government
- Collaborators
- National AIDS Control Organisation, Indian Council of Medical Research
- Investigators
- Soumya Swaminathan, MD, Principal investigator, Tuberculosis Research Centre, IndiaPR Narayanan, PhD, Study director, Tuberculosis Research Centre, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332306
- Sponsor's protocol ID
- trc23
- Status last verified
- Jan 2009
- First submitted
- 30 May 2006
- Last updated
- 8 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jack C, Lalloo U, Karim QA, Karim SA, El-Sadr W, Cassol S, Friedland G. A pilot study of once-daily antiretroviral therapy integrated with tuberculosis directly observed therapy in a resource-limited setting. J Acquir Immune Defic Syndr. 2004 Aug 1;36(4):929-34. doi: 10.1097/00126334-200408010-00006.
PubMed 15220699Patel A, Patel K, Patel J, Shah N, Patel B, Rani S. Safety and antiretroviral effectiveness of concomitant use of rifampicin and efavirenz for antiretroviral-naive patients in India who are coinfected with tuberculosis and HIV-1. J Acquir Immune Defic Syndr. 2004 Sep 1;37(1):1166-9. doi: 10.1097/01.qai.0000135956.96166.f0.
PubMed 15319677Maggiolo F, Migliorino M, Maserati R, Pan A, Rizzi M, Provettoni G, Rizzi L, Suter F; Once Study Group. Virological and immunological responses to a once-a-day antiretroviral regimen with didanosine, lamivudine and efavirenz. Antivir Ther. 2001 Dec;6(4):249-53.
PubMed 11878406Landman R, Schiemann R, Thiam S, Vray M, Canestri A, Mboup S, Kane CT, Delaporte E, Sow PS, Faye MA, Gueye M, Peytavin G, Dalban C, Girard PM, Ndoye I; Imea 011/ANRS 12-04 Study Group. Once-a-day highly active antiretroviral therapy in treatment-naive HIV-1-infected adults in Senegal. AIDS. 2003 May 2;17(7):1017-22. doi: 10.1097/00002030-200305020-00010.
PubMed 12700451Burman WJ, Jones BE. Treatment of HIV-related tuberculosis in the era of effective antiretroviral therapy. Am J Respir Crit Care Med. 2001 Jul 1;164(1):7-12. doi: 10.1164/ajrccm.164.1.2101133. No abstract available.
PubMed 11435232J. M. Molina, S Perusat, F Ferchal, C Rancinan, F raffi, W Rozenbaum, D Sereni, P Morlat, G Chene and the Montana Study Group: Once-Daily Combination Therapy with Emtricitabine, Didanosine and Efavirenz in Treatment-Naïve HIV-Infected Adults: 64-week Follow-Up of the ANRS 091 Trial.
Ribera E, Pou L, Lopez RM, Crespo M, Falco V, Ocana I, Ruiz I, Pahissa A. Pharmacokinetic interaction between nevirapine and rifampicin in HIV-infected patients with tuberculosis. J Acquir Immune Defic Syndr. 2001 Dec 15;28(5):450-3. doi: 10.1097/00042560-200112150-00007.
PubMed 11744833Narendran G, Menon PA, Venkatesan P, Vijay K, Padmapriyadarsini C, Ramesh Kumar S, Bhavani KP, Sekar L, Gomathi SN, Chandrasekhar C, Kumar S, Sridhar R, Swaminathan S. Acquired rifampicin resistance in thrice-weekly antituberculosis therapy: impact of HIV and antiretroviral therapy. Clin Infect Dis. 2014 Dec 15;59(12):1798-804. doi: 10.1093/cid/ciu674. Epub 2014 Aug 25.
PubMed 25156114Swaminathan S, Padmapriyadarsini C, Venkatesan P, Narendran G, Ramesh Kumar S, Iliayas S, Menon PA, Selvaraju S, Pooranagangadevi NP, Bhavani PK, Ponnuraja C, Dilip M, Ramachandran R. Efficacy and safety of once-daily nevirapine- or efavirenz-based antiretroviral therapy in HIV-associated tuberculosis: a randomized clinical trial. Clin Infect Dis. 2011 Oct;53(7):716-24. doi: 10.1093/cid/cir447.
PubMed 21890776
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Two Different Once Daily Anti Retroviral Treatment Regimens Along With Anti-tuberculosis Treatment in Patients With HIV-1 and Tuberculosis
- ClinicalTrials.gov ID
- NCT00332306
- Acronym / sponsor ID
- trc23
- Keywords
- Once daily antiretroviral treatment, Concomitant antituberculosis treatment, HIV Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Tuberculosis Research Centre, IndiaOther government
- Collaborators
- National AIDS Control Organisation, Indian Council of Medical Research
- Study start
- Jun 2006
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 1 Jun 2006 (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.
Protocol Summary
Title: Evaluation of safety and efficacy of two different once daily anti-retroviral treatment regimens along with anti-tuberculosis treatment in patients with HIV-1 and tuberculosis - Randomized Controlled Clinical Trial
Phase: Phase III trial
Population: 180 HIV-1 positive patients with tuberculosis
Number of Sites: Four.
- Tuberculosis Research Centre, Chennai
- Government Medical College, Vellore
- Government Hospital of Thoracic Medicine, Tambaram
- Government Rajaji Hospital, Madurai
Study Duration: 26 months including 24 months of ART.
Study Objectives:
Primary Objective To compare the efficacy and safety of two different once-daily anti-retroviral treatment regimens (along with standard anti-tuberculosis treatment) in patients with HIV-1 and tuberculosis, by using virologic end points.
Secondary Objective To compare the efficacy of antiretroviral treatment given under partial supervision with unsupervised treatment (once a month supply).
Detailed description
Description of Agent or Intervention:
The study intervention is to start patients with HIV and tuberculosis on anti-retroviral treatment along with the continuation phase of anti-tuberculosis treatment (ATT)ie after completion of first two months of treatment. The anti-TB regimen used in this trial will be 2EHRZ3/4RH3. Two different once-daily regimens are being compared for their efficacy and adverse event profile, namely ddI + 3TC + NVP versus ddI + 3TC + EFZ. The primary aim is to study the outcome of patients treated with both ART and ATT at 6 months (24 weeks of ART). A secondary objective is to compare the utility of partially supervised directly observed treatment with unsupervised administration of anti-retroviral drugs.
Patients with HIV-1 infection and active tuberculosis (pulmonary and extrapulmonary) will be started on a four-drug intermittent short-course anti-TB regimen on recruitment to the trial. They will be randomized at the end of intensive phase of ATT to receive either of the ART regimens and the outcome measured at the end of 6 months. During this phase, both ATT and ART will be given under supervision three times a week. Patients with viral load < 400 copies/ml(favourable outcome) at this time point will be randomized to receive ART either by partial observation of treatment (three times a week)or monthly supply (unsupervised administration) and final outcome will be measured at the end of 24 months of ART. The study will provide information on the comparative efficacy of the two regimens when given with anti-TB treatment as well as any added advantage that direct observation of treatment may provide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: Didanosine, Lamivudine, NevirapineDidanosine + Lamivudine + Nevirapine |
| 1 | Active comparator | Drug: Didanosine, Lamivudine, EfavirenzDidanosine + Lamivudine + Efavirenz |
Who may qualify
- Ages
- 18 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age > 18 years
- a) Newly diagnosed sputum smear positive tuberculosis (at least 1 out of 6 sputum specimen should be positive by smear) b)Miliary tuberculosis, mediastinal/hilar lymphadenopathy, diagnosed by chest radiography or CT scan (irrespective of sputum smear status).
- c)TB lymphadenitis with histopathological/bacteriological evidence of TB d)Pleural effusion with biochemical/cytological/bacteriological evidence of TB
- HIV-1 positivity (on 2 different rapid tests on the same blood sample)
- CD4 cell counts less than 250 cells/mm3
Key exclusion criteria (12 listed)
- Resides outside area of intake.
- Pregnancy and lactation.
- Patients with major psychiatric illnesses and severe depression
- Major complications of HIV disease like encephalopathy, renal (Serum creatinine level > 1.2 mgs/dl) or hepatic disease (Serum bilirubin > 2.0 times upper limit of normal, Serum transaminases > 2.5 times upper limit of normal), serum amylase > 2 times upper limit of normal with serum lipase > 1.5 times upper limit of normal.
- Serious cardiac disease (CCF, IHD), uncontrolled diabetes mellitus, cancer, moribund state
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 |
|---|---|---|
| Didanosine, Lamivudine, EfavirenzDidanosine 250mg patients <60kg, 400mg patients > 60kg once daily Lamivudine 300 mg once daily Efavirenz 600 mg once daily All drugs will be given for 24 months | Drug | 1 |
| Didanosine, Lamivudine, NevirapineDidanosine 250 mg once daily for patients < 60kg, 400 mg OD patients > 60kg Lamivudine 300 mg once daily Nevirapine 400 mg once daily All drugs will be given for 24 months | Drug | 2 |
Primary outcome
Suppression of Viral load to < 400 copies/ml or a two log reduction in viral load from the baseline value at the end of 6 months and a viral load <400 copies/ml at 24 months of antiretroviral therapy
Time frame: Dec 2008
2 secondary outcomes
To compare the response to treatment between partially supervised drug administration and unsupervised drug administration.
Time frame: Dec 2009
To compare the tolerability and toxicity attributable to study drugs.
Time frame: Dec 2009
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2009.
- Background: PubMed 15220699Jack C, Lalloo U, Karim QA, Karim SA, El-Sadr W, Cassol S, Friedland G. A pilot study of once-daily antiretroviral therapy integrated with tuberculosis directly observed therapy in a resource-limited setting. J Acquir Immune Defic Syndr. 2004 Aug 1;36(4):929-34. doi: 10.1097/00126334-200408010-00006.
- Background: PubMed 15319677Patel A, Patel K, Patel J, Shah N, Patel B, Rani S. Safety and antiretroviral effectiveness of concomitant use of rifampicin and efavirenz for antiretroviral-naive patients in India who are coinfected with tuberculosis and HIV-1. J Acquir Immune Defic Syndr. 2004 Sep 1;37(1):1166-9. doi: 10.1097/01.qai.0000135956.96166.f0.
- Background: PubMed 11878406Maggiolo F, Migliorino M, Maserati R, Pan A, Rizzi M, Provettoni G, Rizzi L, Suter F; Once Study Group. Virological and immunological responses to a once-a-day antiretroviral regimen with didanosine, lamivudine and efavirenz. Antivir Ther. 2001 Dec;6(4):249-53.
- Background: PubMed 12700451Landman R, Schiemann R, Thiam S, Vray M, Canestri A, Mboup S, Kane CT, Delaporte E, Sow PS, Faye MA, Gueye M, Peytavin G, Dalban C, Girard PM, Ndoye I; Imea 011/ANRS 12-04 Study Group. Once-a-day highly active antiretroviral therapy in treatment-naive HIV-1-infected adults in Senegal. AIDS. 2003 May 2;17(7):1017-22. doi: 10.1097/00002030-200305020-00010.
- Background: PubMed 11435232Burman WJ, Jones BE. Treatment of HIV-related tuberculosis in the era of effective antiretroviral therapy. Am J Respir Crit Care Med. 2001 Jul 1;164(1):7-12. doi: 10.1164/ajrccm.164.1.2101133. No abstract available.
- BackgroundJ. M. Molina, S Perusat, F Ferchal, C Rancinan, F raffi, W Rozenbaum, D Sereni, P Morlat, G Chene and the Montana Study Group: Once-Daily Combination Therapy with Emtricitabine, Didanosine and Efavirenz in Treatment-Naïve HIV-Infected Adults: 64-week Follow-Up of the ANRS 091 Trial.
- Background: PubMed 11744833Ribera E, Pou L, Lopez RM, Crespo M, Falco V, Ocana I, Ruiz I, Pahissa A. Pharmacokinetic interaction between nevirapine and rifampicin in HIV-infected patients with tuberculosis. J Acquir Immune Defic Syndr. 2001 Dec 15;28(5):450-3. doi: 10.1097/00042560-200112150-00007.
- Derived from this study: PubMed 25156114Narendran G, Menon PA, Venkatesan P, Vijay K, Padmapriyadarsini C, Ramesh Kumar S, Bhavani KP, Sekar L, Gomathi SN, Chandrasekhar C, Kumar S, Sridhar R, Swaminathan S. Acquired rifampicin resistance in thrice-weekly antituberculosis therapy: impact of HIV and antiretroviral therapy. Clin Infect Dis. 2014 Dec 15;59(12):1798-804. doi: 10.1093/cid/ciu674. Epub 2014 Aug 25.
- Derived from this study: PubMed 21890776Swaminathan S, Padmapriyadarsini C, Venkatesan P, Narendran G, Ramesh Kumar S, Iliayas S, Menon PA, Selvaraju S, Pooranagangadevi NP, Bhavani PK, Ponnuraja C, Dilip M, Ramachandran R. Efficacy and safety of once-daily nevirapine- or efavirenz-based antiretroviral therapy in HIV-associated tuberculosis: a randomized clinical trial. Clin Infect Dis. 2011 Oct;53(7):716-24. doi: 10.1093/cid/cir447.
- National AIDS Control OrganisationLink 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.
Soumya Swaminathan, MD principal investigator
Tuberculosis Research Centre, India
PR Narayanan, PhD study director
Tuberculosis Research Centre, India
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 Didanosine, Lamivudine, Efavirenz and Didanosine, Lamivudine, Nevirapine in people with Tuberculosis and Human Immunodeficiency Virus Infections, run by Tuberculosis Research Centre, India at 1 site in India.
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 10 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 8 Oct 2009. 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 India. 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?
Results are not available in the source record.
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?
Suppression of Viral load to < 400 copies/ml or a two log reduction in viral load from the baseline value at the end of 6 months and a viral load <400 copies/ml at 24 months of antiretroviral therapy (time frame: Dec 2008). 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 NCT00332306, which also lists 9 linked publications.
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 8 Oct 2009.