Phase 4
N=1,045
Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00084136 ↗Enrolled (actual)
1,045
Serious AEs
14.3%
Results posted
Aug 2011
Primary outcome: Primary: Time to Treatment Failure (PI Comparison) — 16; 16; 40; 24 weeks — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Atazanavir (Drug); Didanosine (enteric-coated) (Drug); Efavirenz (Drug); Emtricitabine (Drug); Emtricitabine/Tenofovir disoproxil fumarate (Drug); Lamivudine/Zidovudine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Treatment Failure (PI Comparison) |
16; 16; 40; 24; NA; 120 | <0.01 sig |
| PRIMARY Time to Treatment Failure (NRTI Comparison) |
16; 16; 40; 40; NA; NA | — |
| SECONDARY Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) |
16; 7; 34; 18; NA; 76 | — |
| SECONDARY Time to Immunologic Failure (PI Comparison) |
48; 48; 112; NA | — |
| SECONDARY Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) |
112.5; 146.5; 152.0; 187.0; 216.0; 256.0 | — |
| SECONDARY Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) |
4; 4; 12; 32; 96; 144 | — |
| SECONDARY Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison) |
459; 431; 437; 424 | — |
| SECONDARY Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) |
0; 0; 16; 0; NA; 48 | — |
| SECONDARY Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) |
0; 0; 0; 0; 32; 48 | — |
| SECONDARY Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) |
16; 18; 34; 36; 163; 201 | — |
| SECONDARY Time to Immunologic Failure (NRTI Comparison) |
48; 48; 128; 104; NA; NA | — |
| SECONDARY Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison) |
112.5; 120.5; 151.5; 159; 220.5; 226 | — |
| SECONDARY Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison) |
459; 448; 442; 455 | — |
| SECONDARY Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) |
0; 0; 16; 24 | — |
| SECONDARY Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) |
0; 0; 16; 24; NA; NA | — |
| SECONDARY Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) |
0; 0; 0; 0; 32; NA | — |
| SECONDARY Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) |
0; 0; 0; 0; 32; NA | — |
| SECONDARY Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison) |
4; 4; 12; 32; 112; 224 | — |
Summary
This study compared 3 different three-drug combinations in HIV infected individuals starting their first HIV treatment regimens. Participants were recruited from resource-limited areas in Africa, Asia, South America, Haiti, and also from the United States. The study hypothesis was each of the once daily combinations (PI based, or NNRTI based) would not have inferior efficacy compared to the twice daily NNRTI based combination.
Eligibility Criteria
Inclusion Criteria :>
- HIV-1 infected>
- CD4 count fewer than 300 cells/mm3 >
- Viral load test result>
- Absolute Neutrophil Count at least 750mm3 >
- Hemoglobin at least 7.5 g/dL>
- Platelet count at least 50,000/mm3>
- Calculated creatinine clearance at least 60 mL/min>
- A , A, and alkaline phosphatase
- total bilirubin
- Karnofsky performance score of 70 or higher>
- Plans to stay in the area for the duration of the study>
- Agrees to use acceptable forms of contraception for the duration of the study>
Exclusion Criteria:>
- More than 7 days exposure to ARVs (except for single-dose NVP or ZDV for any period for the purpose of pMTCT)>
- Acute therapy for serious medical illnesses within 14 days prior to study entry>
- Certain abnormal laboratory values>
- Radiation therapy or chemotherapy within 45 days prior to study entry. >
- Any immunomodulator, HIV vaccine, or other investigational therapy within 30 days prior to study entry. >
- Current alcohol or drug abuse that, in the opinion of the site investigator, would interfere with study participation>
- Inflamed pancreas within 3 years prior to study entry>
- Allergy/sensitivity to any of the study drugs or their formulations>
- Heart rate less than 40 beats/min>
- History of untreated, active second- or third-degree heart block>
- Currently detained in jail or for treatment of a psychiatric or physical illness>
- Vomiting or inability to swallow medications>
- Pregnancy>
Data sourced from ClinicalTrials.gov (NCT00084136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.